Events

TEXTURIZED GEL MELLAR IMPLANTS (PERTHESE® ESTHEA Silicone gel-filled breast implant - textured - 210 cc) - Record 80145901328 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde 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
    1377
  • 날짜
    2014-04-04
  • 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 company reports that to date, there are no reports of customers reporting product complaints or adverse events related to this problem. According to the risk analysis of the manufacturer, in relation to the deviation found, it is unlikely that an adverse health consequence will occur.
  • 원인
    The company holding the registration informs that the manufacturer has identified that some units of the texturized gel mammary implants product manufactured between 2002 and 2010 were identified with an incorrect expiration date and distributed to some countries between 2006 and 2010, in addition to the date of expiration. this deviation was detected after reviewing the quality data in december 2013.
  • 조치
    The company asks physicians who have used the product to verify the period of coverage of this field action, as well as the product code, serial number and lot involved (Appendix I - Customer Letter). The company also recommends that the physician monitor patients according to standard protocols. If there is any medical doubt, the professional should contact the local representatives for the best assistance.

Device

TEXTURIZED GEL MELLAR IMPLANTS (PERTHESE® ESTHEA Silicone gel-filled breast implant - textured - ...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda