Events

INTRODUCTION GUIDELINES USED IN ORTHOPEDICS AND TRAUMATOLOGY FOR THE GUIDED CANULATION OF SCREWS SYSTEMS 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 (1) B BRAUN MEDICAL LTDA.; (2) BIOMET MERCK LTDA.; (3) DE PUY INTERNATIONAL LTDA.; (4) SMITH & NEPHEW PLC; (5) STRATEC MEDICAL LTDA.; (6) STRYKER HOWMEDICA OSTEONICS DIV STRYKER CORP.; (7) ZIMMER 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
    47
  • 날짜
    2001-06-01
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • 원인
    Medical devices agency, mda / uk, laid an alert due to the report of a fatal incident, in which a canulated drill went into the introduction guide and advanced about the pelvis reaching the ilíaca veia. mda alert on the risk of advancing guidelines for underlying tissues during procedures involving insertion, scratching, inserting screws and screwing through guides with canulated instruments.
  • 조치
    MEDICAL DEVICES AGENCY, MDA / UK, RECOMMENDS THAT PROFESSIONALS: (1) VERIFY THE POSITION OF THE INTRODUCTION GUIDELINES WITH IMAGE INTENSIFIER (FLUOROSCOPY) FREQUENTLY TO AVOID ADVANCEMENT AND PENETRATION IN THE ADJACENT FABRICS. (2) CLEANING THE CANULATED INSTRUMENTS DURING OPERATION TO AVOID BONE PARTICULATE ACULVULATION IN THE CELL. FOR TECHNICAL INVESTIGATIONS, MEDICAL DEVICES AGENCY, MDA / UK, HAS PLACED TWO EXPERTS IN DISPOSAL, DRS. J. COOKE OR DR. J. SHAW (FAX: 0021-44-207-972-8106, PHONE 0021-44-207-972-8267 OR 8343 OR MAIL, HANNIBAL HOUSE, ELEPHANT AND CASTLE, LONDON SE1 6TQ, ENGLAND). FOR CLINICAL RESEARCH, DR. J. HOPPER (FAX: 0021-44-207-972-8103, PHONE 0021-44-207-972-8126 OR BY MAIL, HANNIBAL HOUSE, ELEPHANT AND CASTLE, LONDON SE1 6TQ, ENGLAND). FOR ALL INVESTIGATIONS, CIT THE REFERENCE NO. 20000519011-8.

Device

INTRODUCTION GUIDELINES USED IN ORTHOPEDICS AND TRAUMATOLOGY FOR THE GUIDED CANULATION OF SCREWS ...

Manufacturer

(1) B BRAUN MEDICAL LTDA.; (2) BIOMET MERCK LTDA.; (3) DE PUY INTERNATIONAL LTDA.; (4) SMITH & NE...
  • Source
    ANVSANVISA