Events

All products produced by the company Meta Bio Industrial Ltda for valid product registrations, these being: 80034760001; 80034760003; 80034760004; 80034760005; 80034760006; 80034760007; 80034760008; 80034760009; 80034760010; 80034760011; 80034760012; 80034760014; 80034760015; 80034760016; 80034760017; 80034760018; 80034760019; 80034760020; 80034760021; 80034760022; 80034760023; 80034760024; 80034760025; 80034760026; 80034760027; 80034760028; 80034760029; 80034760030; 80034760031; 80034760032; 80034760033; 80034760034; 80034760035; 80034760036; 80034760037; 80034760038; 80034760039; 80034760040; 80034760041; 80034760042; 80034760043; 80034760044; 80034760045; 80034760046; 80034760047; 80034760048; 80034760049; 80034760050; 80034760050; 80034760051; 80034760052; 80034760053; 80034760054; 80034760055; 80034760056; 80034760057; 80034760058; 80034760059; 80034760060; 80034769001 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Meta Bio Industrial Ltda. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 ID
    1780
  • 날짜
    2015-12-21
  • 사례 국가
    Brazil
  • 사례 출처
    ANVISA
  • 사례 출처 URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 비고 / 경고
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • 데이터 추가 비고
    The UI, although not in accordance with the latest version of the registry, provides all necessary information regarding the manufacturer's information, indications of use for each type of product / product line, contraindications, special care, postoperative complications, information to the patient, adverse effects, information to the attending physician, conditions and precautions with transportation, handling, storage and preservation, product traceability, product disposal, safe implant removal, identification of product records and all information necessary to that any person or institution can contact Meta Bio or ANVISA via Notivisa. It is important to note that so far there has been no technical complaint, consultation of clients or any health professional questioning the current instructions for use or the content thereof.
  • 원인
    The instructions for use on the products (all registrations) were not in accordance with the latest versions published and approved in their respective anvisa product registers.
  • 조치
    a) Risk classification: III b) Classification of the field action: Update, correction or compelmentation of the Instructions for Use c) Field action code: IU / 2015 d) recommendations to users and patients: By publishing the Alert Message Meta Bio, we request that our Distributors disregard the Instructions for Use currently packaged with the products and then consider those published electronically on the Meta Bio website. It is not necessary to follow-up the implanted patients, since the Instruction of Use is not for the lay public and contains information necessary for the due contacts of any type of complaint or adverse event.

Device

All products produced by the company Meta Bio Industrial Ltda for valid product registrations, th...

Manufacturer

Meta Bio Industrial Ltda.