Bronchoscope FN-53A, Larynx-Fibro Pediatric FN-40A and flexible endoscopes. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 HUGER ENDOSCOPY INSTRUMENTS CO., LTD; Brazilian Endoscope Industria e Comercio de Equipamentos Medicos Ltda./ENDOBRAX 에 의해 제조된 제품과 관련되어 있습니다.

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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
    1278
  • 날짜
    2013-07-02
  • 사례 국가
  • 사례 출처
    ANVISA
  • 사례 출처 URL
  • 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 Technovigilance Unit will be monitoring and evaluating the effectiveness of the collection of the products./////// UPDATE - 08/13/2014 - Published Resolution - RE n. 3,047 dated August 12, 2014. DOU n ° 154, of 08/13/2014, considering the contents of the Investigation Report of the Superintendency of Sanitary Surveillance of the State of Minas Gerais, whose findings detected a typo when the Brazilian company Endoscope Indústria e Comércio de Equipamentos Médicos Ltda./ENDOBRAX (CNPJ: 07.427.470 / 0001-85), causing incorrect coding and, therefore, the lack of a registration number in the electronic system of this Agency. The company corrected the typo on its website, as documented in the mentioned report.
  • 원인
    Marketing of health products without registration./////// update - 08/13/2014 - the superintendency of sanitary surveillance of the state of minas gerais issued a research report stating that a typo was identified when developing the electronic site of the company brazilian endoscope indústria e comércio de equipamentos médicos ltda./endobrax, causing incorrect coding and, therefore, the lack of a registration number in the electronic system of this agency. the error has already been fixed.
  • 조치
    To determine, as a measure of health interest, the suspension of the importation, distribution, disclosure, trade and use of the FN-40A Bronchoscope, Fibro Laringo-Bronco Pediatric FN-40A products and flexible endoscopes, as well as collection of the products specified above. // UPDATE - 08/13/2014 - Repeal of Resolution RE No. 2.286, of July 1, 2013. DOU n ° 125, of 07/02/2013., Through Resolution - RE n. 3,047 of August 12, 2014. DOU No. 154, of 08/13/2014.