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[PMID]:29016511
[Au] Autor:Clark NM; Schembri M; Jacoby VL
[Ad] Endereço:University of California, San Francisco School of Medicine, and the Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco, San Francisco, California.
[Ti] Título:Change in Surgical Practice for Women With Leiomyomas After the U.S. Food and Drug Administration Morcellator Safety Communication.
[So] Source:Obstet Gynecol;130(5):1057-1063, 2017 Nov.
[Is] ISSN:1873-233X
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:OBJECTIVE: To evaluate the association between the U.S. Food and Drug Administration (FDA) communication discouraging use of power morcellators on changes in surgical practice for women with uterine leiomyomas. METHODS: This is a cross-sectional study using data from 2013 to 2014 in the Healthcare Cost and Utilization Project State Inpatient and State Ambulatory Surgical Databases from Arizona, Florida, Kentucky, and New Jersey. Women with a diagnosis of leiomyomas who underwent hysterectomy or myomectomy were included in the analysis. Multivariable models were used to assess changes in the proportion of hysterectomies performed laparoscopically, vaginally, or by laparotomy in the 15 months before the FDA safety communication in April 2013 (January 2013 to March 2014) to the 9 months after the FDA communication (April to December 2014). Changes in the proportion of women who underwent myomectomy compared with hysterectomy were also evaluated during this time period. RESULTS: There were 77,637 hysterectomy and myomectomy cases analyzed from states with both inpatient and ambulatory surgery data; 59% of patients were outpatients. Overall, there was a 4% (95% CI 3.2-4.8%) decrease in the use of laparoscopic hysterectomy for treatment of uterine leiomyomas from 62% of all hysterectomies before the FDA communication on morcellation to 58% afterward. Changes in surgical practice were more pronounced in the inpatient compared with outpatient setting; inpatient laparoscopic hysterectomy decreased by 7% (95% CI 6.1-7.9%) from 24% to 17% of all hysterectomies with an accompanying increase in abdominal hysterectomy of 8% (95% CI 6.7-8.6%) from 71% to 79%. There were no significant changes in the proportion of women with leiomyomas who underwent myomectomy compared with hysterectomy. CONCLUSION: The FDA communication discouraging the use of power morcellators was associated with a decline in laparoscopy to perform hysterectomy, particularly in the inpatient setting. There was no change in the selection of myomectomy compared with hysterectomy for leiomyoma treatment after the FDA communication.
[Mh] Termos MeSH primário: Histerectomia/tendências
Laparoscopia/tendências
Leiomioma/cirurgia
Morcelação/instrumentação
Retirada de Dispositivo Médico Baseada em Segurança
Miomectomia Uterina/tendências
Neoplasias Uterinas/cirurgia
[Mh] Termos MeSH secundário: Adulto
Arizona
Estudos Transversais
Bases de Dados Factuais
Feminino
Florida
Seres Humanos
Histerectomia/instrumentação
Histerectomia/métodos
Kentucky
Laparoscopia/métodos
Meia-Idade
Análise Multivariada
New Jersey
Estados Unidos
United States Food and Drug Administration
Miomectomia Uterina/instrumentação
Miomectomia Uterina/métodos
[Pt] Tipo de publicação:EVALUATION STUDIES; JOURNAL ARTICLE
[Em] Mês de entrada:1711
[Cu] Atualização por classe:171102
[Lr] Data última revisão:
171102
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:171011
[St] Status:MEDLINE
[do] DOI:10.1097/AOG.0000000000002309


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[PMID]:28655037
[Au] Autor:Ibrahim AM; Dimick JB
[Ad] Endereço:Center for Healthcare Outcomes and Policy, University of Michigan, Ann Arbor.
[Ti] Título:Monitoring Medical Devices: Missed Warning Signs Within Existing Data.
[So] Source:JAMA;318(4):327-328, 2017 07 25.
[Is] ISSN:1538-3598
[Cp] País de publicação:United States
[La] Idioma:eng
[Mh] Termos MeSH primário: Gastroplastia/instrumentação
Vigilância de Produtos Comercializados
[Mh] Termos MeSH secundário: Segurança de Equipamentos
Seres Humanos
Obesidade Mórbida/cirurgia
Vigilância de Produtos Comercializados/métodos
Reoperação/economia
Retirada de Dispositivo Médico Baseada em Segurança
Estados Unidos
United States Food and Drug Administration
[Pt] Tipo de publicação:JOURNAL ARTICLE; RESEARCH SUPPORT, N.I.H., EXTRAMURAL; RESEARCH SUPPORT, U.S. GOV'T, NON-P.H.S.
[Em] Mês de entrada:1709
[Cu] Atualização por classe:171127
[Lr] Data última revisão:
171127
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:170628
[St] Status:MEDLINE
[do] DOI:10.1001/jama.2017.6584


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[PMID]:27008058
[Au] Autor:Giuliano KK; Niemi C
[Ad] Endereço:Karen K. Giuliano is a postdoctoral research fellow at Yale University School of Nursing in New Haven, Conn. Charles Niemi was a biomedical engineer at Dartmouth-Hitchcock Medical Center in Lebanon, N.H., at the time this article was written.
[Ti] Título:The urgent need for innovation in I.V. infusion devices.
[So] Source:Nursing;46(4):66-8, 2016 Apr.
[Is] ISSN:1538-8689
[Cp] País de publicação:United States
[La] Idioma:eng
[Mh] Termos MeSH primário: Difusão de Inovações
Bombas de Infusão
[Mh] Termos MeSH secundário: Bases de Dados Factuais
Seres Humanos
Infusões Intravenosas/enfermagem
Liderança
Papel do Profissional de Enfermagem
Retirada de Dispositivo Médico Baseada em Segurança
Estados Unidos
United States Food and Drug Administration
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Em] Mês de entrada:1608
[Cu] Atualização por classe:170220
[Lr] Data última revisão:
170220
[Sb] Subgrupo de revista:N
[Da] Data de entrada para processamento:160324
[St] Status:MEDLINE
[do] DOI:10.1097/01.NURSE.0000480617.62296.d7


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[PMID]:26584802
[Au] Autor:Samuel AM; Rathi VK; Grauer JN; Ross JS
[Ad] Endereço:Department of Orthopaedics and Rehabilitation, Yale School of Medicine, 800 Howard Ave, New Haven, CT, 06510, USA.
[Ti] Título:How do Orthopaedic Devices Change After Their Initial FDA Premarket Approval?
[So] Source:Clin Orthop Relat Res;474(4):1053-68, 2016 Apr.
[Is] ISSN:1528-1132
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: The FDA approves novel, high-risk medical devices through the premarket approval (PMA) process based on clinical evidence supporting device safety and effectiveness. Devices subsequently may undergo postmarket modifications that are approved via one of several PMA supplement review tracks, usually without additional supporting clinical data. While orthopaedic devices cleared via the less rigorous 510(k) pathway have been studied previously, devices cleared through the PMA pathway and those receiving postmarket PMA supplements warrant further investigation. QUESTIONS/PURPOSES: We asked: What are (1) the types of original orthopaedic devices receiving FDA PMA approval, (2) the number and rate of postmarket device changes approved per device, (3) the types of PMA supplement review tracks used, (4) the types of device changes approved via the various review tracks, and (5) the number of device recalls and market withdrawals that have occurred for these devices? METHODS: All original PMA-approved orthopaedic devices between January 1982 and December 2014 were identified in the publically available FDA PMA database. The number of postmarket device changes approved, the PMA supplement review track used, the types of postmarket changes, and any FDA recalls for each device were assessed. RESULTS: Seventy original orthopaedic devices were approved via the FDA PMA pathway between 1982 and 2014. These devices included 34 peripheral joint implants or prostheses, 18 spinal implants or prostheses, and 18 other devices or materials. These devices underwent a median 6.5 postmarket changes during their lifespan or 1.0 changes per device-year (interquartile range, 0.4-1.9). The rate of new postmarket device changes approved per active device, increased from less than 0.5 device changes per year in 1983 to just fewer than three device changes per year in 2014, or an increase of 0.05 device changes per device per year in linear regression analysis (95% CI, 0.04-0.07). Among the 765 total postmarket changes, 172 (22%) altered device design or components. The majority of the design changes were reviewed via either the real-time review track (n = 98; 57%), intended for minor design changes, or the 180-day review track (n = 71; 41%), intended for major design changes. Finally, a total of 12 devices had FDA recalls at some point during their lifespan, two being for hip prostheses with high revision rates. CONCLUSIONS: Relatively few orthopaedic devices undergo the FDA PMA process before reaching the market. Orthopaedic surgeons should be aware that high-risk medical devices cleared via the FDA's PMA pathway do undergo considerable postmarket device modification after reaching the market, with potential for design "drift," ie, shifting away from the initially tested and approved device designs. CLINICAL RELEVANCE: As the ultimate end-users of these devices, orthopaedic surgeons should be aware that even among high-risk medical devices approved via the FDA's PMA pathway, considerable postmarket device modification occurs. Continued postmarket device monitoring will be essential to limit patient safety risks.
[Mh] Termos MeSH primário: Aprovação de Equipamentos
Equipamentos Ortopédicos
Procedimentos Ortopédicos/instrumentação
Vigilância de Produtos Comercializados
United States Food and Drug Administration
[Mh] Termos MeSH secundário: Estudos Transversais
Bases de Dados Factuais
Desenho de Equipamento
Seres Humanos
Recall de Dispositivo Médico
Equipamentos Ortopédicos/efeitos adversos
Procedimentos Ortopédicos/efeitos adversos
Segurança do Paciente
Estudos Retrospectivos
Fatores de Risco
Retirada de Dispositivo Médico Baseada em Segurança
Fatores de Tempo
Estados Unidos
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1607
[Cu] Atualização por classe:170403
[Lr] Data última revisão:
170403
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:151121
[St] Status:MEDLINE
[do] DOI:10.1007/s11999-015-4634-x


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[PMID]:26472480
[Au] Autor:Fenoll C; Leclère FM; Hivelin M; Atlan M; Cothier-Savey I; Lantieri L; Le Masurier P
[Ad] Endereço:Service de chirurgie reconstructrice, hôpital René-Huguenin, institut Curie, 35, rue Dailly, 92210 Saint-Cloud, France; Service de chirurgie plastique, hôpital Saint-Joseph, 185, rue Raymond-Losserand, 75014 Paris, France. Electronic address: claire.fenoll@gmail.com.
[Ti] Título:[Poly Implant Prothèse (PIP®) incidence of complications in breast reconstructive surgery: A retrospective comparative analysis].
[Ti] Título:Poly Implant Prothèse (PIP®) et incidence des complications en reconstruction mammaire: une étude rétrospective contrôlée..
[So] Source:Ann Chir Plast Esthet;60(6):478-83, 2015 Dec.
[Is] ISSN:1768-319X
[Cp] País de publicação:France
[La] Idioma:fre
[Ab] Resumo:INTRODUCTION: On 29 March 2010, the Poly Implant Prothèse (PIP(®)) breast prosthesis was withdrawn from the market by the ANSM. In this study we review our experience with PIP(®) implants in breast reconstruction. We compare our complications with other types of breast implants used during the same period at our institution. PATIENTS AND METHOD: This is a retrospective study conducted at the Hospital René Huguenin of the Institut Curie (Paris, France). It includes 327 prostheses, from 268 patients who underwent surgery for breast reconstruction between February 2008 and February 2012: 69 PIP(®) (Group 1), 82 Mentor(®) (Group 2) and 179 Allergan(®) (Group 3). The objective of the study was to compare the rates of early and late complications for each prosthesis. Our results are compared with the current literature. RESULTS: With regard to the rate of early complications (hematoma, infection, seroma, wound dehiscence), no difference was observed between the three groups (P not significant). However, the study found that 100% of the 13 PIP(®) implants with early complications required surgical revision. There were too few late complications (capsular contracture, prosthetic rupture) in our cohort to allow statistical comparison between the three groups (P not significant). We compare our results with the current literature. CONCLUSION: This study highlights the lack of significant difference in the occurrence of early adverse events between the three groups of implants. This may explain the time taken for surgeons to become aware there was a problem with the PIP(®) implants. The low rate of late complications in our series does not allow statistical analysis between the three groups of implants.
[Mh] Termos MeSH primário: Implantes de Mama/efeitos adversos
Mamoplastia
[Mh] Termos MeSH secundário: Adulto
Idoso
Implantes de Mama/estatística & dados numéricos
Feminino
França
Seres Humanos
Meia-Idade
Complicações Pós-Operatórias
Falha de Prótese
Reoperação
Estudos Retrospectivos
Retirada de Dispositivo Médico Baseada em Segurança
[Pt] Tipo de publicação:COMPARATIVE STUDY; JOURNAL ARTICLE
[Em] Mês de entrada:1702
[Cu] Atualização por classe:170208
[Lr] Data última revisão:
170208
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:151017
[St] Status:MEDLINE


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[PMID]:25692639
[Au] Autor:Giuliano KK; Niemi C
[Ad] Endereço:Karen K. Giuliano is a postdoctoral research fellow at Yale University School of Nursing in New Haven, Conn. Charles Niemi was a biomedical engineer at Dartmouth-Hitchcock Medical Center in Lebanon, N.H., at the time this article was written.
[Ti] Título:The urgent need for innovation in I.V. smart pumps.
[So] Source:Nurs Manage;46(3):17-9, 2015 Mar.
[Is] ISSN:1538-8670
[Cp] País de publicação:United States
[La] Idioma:eng
[Mh] Termos MeSH primário: Difusão de Inovações
Bombas de Infusão
Infusões Intravenosas/enfermagem
Erros de Medicação/prevenção & controle
Gestão de Riscos/organização & administração
[Mh] Termos MeSH secundário: Seres Humanos
Enfermeiras Administradoras
Papel do Profissional de Enfermagem
Segurança do Paciente
Retirada de Dispositivo Médico Baseada em Segurança
Estados Unidos
United States Food and Drug Administration
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1612
[Cu] Atualização por classe:170220
[Lr] Data última revisão:
170220
[Sb] Subgrupo de revista:N
[Da] Data de entrada para processamento:150219
[St] Status:MEDLINE
[do] DOI:10.1097/01.NUMA.0000461066.79777.06


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[PMID]:25262198
[Au] Autor:Gurley BJ; Steelman SC; Thomas SL
[Ad] Endereço:Department of Pharmaceutical Sciences, University of Arkansas for Medical Sciences, College of Pharmacy, Little Rock, Arkansas. Electronic address: gurleybillyj@uams.edu.
[Ti] Título:Multi-ingredient, caffeine-containing dietary supplements: history, safety, and efficacy.
[So] Source:Clin Ther;37(2):275-301, 2015 Feb 01.
[Is] ISSN:1879-114X
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:PURPOSE: Our objective was to review the history, safety, and efficacy of caffeine-containing dietary supplements in the United States and Canada. METHODS: PubMed and Web of Science databases (1980-2014) were searched for articles related to the pharmacology, toxicology, and efficacy of caffeine-containing dietary supplements with an emphasis on Ephedra-containing supplements, Ephedra-free supplements, and energy drinks or shots. FINDINGS: Among the first and most successful dietary supplements to be marketed in the United States were those containing Ephedra­combinations of ephedrine alkaloids, caffeine, and other phytochemicals. A decade after their inception, serious tolerability concerns prompted removal of Ephedra supplements from the US and Canadian markets. Ephedra-free products, however, quickly filled this void. Ephedra-free supplements typically contain multiple caffeine sources in conjunction with other botanical extracts whose purposes can often be puzzling and their pharmacologic properties difficult to predict. Ingestion of these products in the form of tablets, capsules, or other solid dosage forms as weight loss aids, exercise performance enhancers, or energy boosters have once again brought their tolerability and efficacy into question. In addition to Ephedra-free solid dosage forms, caffeine-containing energy drinks have gained a foothold in the world market along with concerns about their tolerability. IMPLICATIONS: This review addresses some of the pharmacologic and pharmaceutical issues that distinguish caffeine-containing dietary supplement formulations from traditional caffeine-containing beverages. Such distinctions may account for the increasing tolerability concerns affiliated with these products.
[Mh] Termos MeSH primário: Cafeína/farmacologia
Estimulantes do Sistema Nervoso Central/farmacologia
Suplementos Nutricionais
Bebidas Energéticas
[Mh] Termos MeSH secundário: Alcaloides/efeitos adversos
Cafeína/efeitos adversos
Canadá
Estimulantes do Sistema Nervoso Central/efeitos adversos
Suplementos Nutricionais/efeitos adversos
Suplementos Nutricionais/história
Combinação de Medicamentos
Bebidas Energéticas/efeitos adversos
Bebidas Energéticas/história
Ephedra/efeitos adversos
Ephedra/química
Efedrina/química
História do Século XX
Seres Humanos
Retirada de Dispositivo Médico Baseada em Segurança
Estados Unidos
[Pt] Tipo de publicação:HISTORICAL ARTICLE; JOURNAL ARTICLE; REVIEW
[Nm] Nome de substância:
0 (Alkaloids); 0 (Central Nervous System Stimulants); 0 (Drug Combinations); 3G6A5W338E (Caffeine); GN83C131XS (Ephedrine)
[Em] Mês de entrada:1511
[Cu] Atualização por classe:150302
[Lr] Data última revisão:
150302
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:140929
[St] Status:MEDLINE


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[PMID]:24843049
[Au] Autor:Demirel F; Adiyaman A; Delnoy PP; Smit JJ; Ramdat Misier AR; Elvan A
[Ad] Endereço:Department of Cardiology, Isala Klinieken, Dr. Van Heesweg 2, 8025 AB, Zwolle, The Netherlands.
[Ti] Título:Mechanical and electrical dysfunction of Riata implantable cardioverter-defibrillator leads.
[So] Source:Europace;16(12):1787-94, 2014 Dec.
[Is] ISSN:1532-2092
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:AIM: Riata implantable cardioverter-defibrillator leads are prone to failure by conductor externalization and/or electrical dysfunction. The objectives of this study were to determine the predictors of the Riata lead failure, to assess the association of conductor externalization and electrical lead failure, and to analyse the rates of lead failure over time. METHODS AND RESULTS: Of 273 implanted Riata leads in our centre, 197 were investigated according to the Riata recall protocol, including electrical measurements by device interrogation and annually fluoroscopy. During a mean follow-up period of 5.6 ± 1.4 years, Riata lead failure was 18.8% (37 of 197) for externalization and 17.3% (34 of 197) for electrical lead failure. Electrical lead failure was correlated with time after implant. Externalization and electrical dysfunction co-existed in only 6 of 197 (3%) patients and were not related (Phi's coefficient -0.013, P = 0.85). During the second annual screening, 145 (73.6%) patients underwent fluoroscopy and 9 patients had novel externalizations resulting in an incidence of 6.72%/patient/year which was higher than expected based on cross-sectional analysis. Besides, there was a significant increase in the extent of externalization (17.65 ± 11.14 mm vs. 21.77 ± 11.95 mm, P = 0.001). In multivariate Cox regression analysis, non-ischaemic cardiomyopathy and impaired LVEF were independent predictors of externalization, and 7 Fr lead was a predictor of electrical lead failure. CONCLUSION: Riata leads show progressive and high externalization rates without correlation between externalization and electrical lead failure. Non-ischaemic cardiomyopathy and impaired LVEF are independent predictors of structural lead failure in cross-sectional analysis, whereas 7 Fr lead is a predictor of electrical lead failure.
[Mh] Termos MeSH primário: Desfibriladores Implantáveis/estatística & dados numéricos
Eletrodos Implantados/estatística & dados numéricos
Falha de Equipamento/estatística & dados numéricos
Segurança de Equipamentos/estatística & dados numéricos
Insuficiência Cardíaca/epidemiologia
Insuficiência Cardíaca/prevenção & controle
Retirada de Dispositivo Médico Baseada em Segurança
[Mh] Termos MeSH secundário: Idoso
Idoso de 80 Anos ou mais
Desenho de Equipamento
Análise de Falha de Equipamento
Feminino
Seres Humanos
Masculino
Recall de Dispositivo Médico
Meia-Idade
Países Baixos/epidemiologia
Prevalência
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1507
[Cu] Atualização por classe:141124
[Lr] Data última revisão:
141124
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:140521
[St] Status:MEDLINE
[do] DOI:10.1093/europace/euu079


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[PMID]:24768305
[Au] Autor:Danvers AA; Stuart GS; Bryant AG
[Ad] Endereço:Department of Obstetrics and Gynecology, University of North Carolina School of Medicine, Chapel Hill, NC 27599, USA. Electronic address: antoinette_danvers@med.unc.edu.
[Ti] Título:Lawsuits against Mirena®: potential impact on public health.
[So] Source:Contraception;89(6):489-92, 2014 Jun.
[Is] ISSN:1879-0518
[Cp] País de publicação:United States
[La] Idioma:eng
[Mh] Termos MeSH primário: Anticoncepcionais Femininos/efeitos adversos
Remoção de Dispositivo
Medicina Baseada em Evidências
Dispositivos Intrauterinos Medicados/efeitos adversos
Levanogestrel/efeitos adversos
Retirada de Dispositivo Médico Baseada em Segurança/legislação & jurisprudência
Saúde da Mulher
[Mh] Termos MeSH secundário: Anticoncepcionais Femininos/administração & dosagem
Feminino
Conhecimentos, Atitudes e Prática em Saúde
Seres Humanos
Internet
Levanogestrel/administração & dosagem
Meios de Comunicação de Massa
Educação de Pacientes como Assunto
Papel do Médico
Retirada de Dispositivo Médico Baseada em Segurança/ética
Responsabilidade Social
Estados Unidos
Saúde da Mulher/educação
[Pt] Tipo de publicação:EDITORIAL
[Nm] Nome de substância:
0 (Contraceptive Agents, Female); 5W7SIA7YZW (Levonorgestrel)
[Em] Mês de entrada:1501
[Cu] Atualização por classe:140526
[Lr] Data última revisão:
140526
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:140429
[St] Status:MEDLINE


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[PMID]:24342906
[Au] Autor:Edlich RF; Garrison JA; Nearents JE
[Ad] Endereço:Distinguished Professor Emeritus of Plastic Surgery, Biomedical Engineering and Emergency Medicine, University of Virginia Health System, Charlottesville, Virginia.
[Ti] Título:The FDA agrees to ban powdered medical and surgical gloves.
[So] Source:J Emerg Med;46(3):e105-6, 2014 Mar.
[Is] ISSN:0736-4679
[Cp] País de publicação:United States
[La] Idioma:eng
[Mh] Termos MeSH primário: Luvas Cirúrgicas/efeitos adversos
Pós/efeitos adversos
Retirada de Dispositivo Médico Baseada em Segurança
Amido/efeitos adversos
[Mh] Termos MeSH secundário: Seres Humanos
Estados Unidos
United States Food and Drug Administration
[Pt] Tipo de publicação:LETTER
[Nm] Nome de substância:
0 (Powders); 9005-25-8 (Starch)
[Em] Mês de entrada:1411
[Cu] Atualização por classe:140303
[Lr] Data última revisão:
140303
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:131218
[St] Status:MEDLINE



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