Events

EXTRACT OF SURGICAL CLAMPS PROXIMATE * - Record 10132590054 - Lots Affected - See annex .. http://portal.anvisa.gov.br/wps/wcm/connect/19c0fb004d632634b56bf5c116238c3b/Lotes_Afetados.pdf?MOD=AJPERES 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
    1197
  • 날짜
    2012-11-09
  • 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
    Ethicon Endo-Surgery has initiated a voluntary recall of all PSX Proximate® Skin Staple Extractors products because of the possibility that damage to the packaging may have compromised the sterility of the product. The problem was detected internally during the packaging process. No customer complaints related to this issue were received, as well as no adverse event reports associated with the product under recall. Ethicon Endo-Surgery has stopped production and shipment of the affected product and is investigating the root cause of the packaging problem and will implement actions to resume production. There are no notifications to date in the NOTIVISA system. Anvisa follows this action.
  • 원인
    Possibility of compromising the sterile barrier of the package.
  • 조치
    Users are advised to: See annex. http://portal.anvisa.gov.br/wps/wcm/connect/35191e004d6326a7b574f5c116238c3b/Carta_aos_Hospitais.pdf?MOD=AJPERES 1. Inspect your inventory immediately to see if you have the affected product, and separate those products. View detailed images to help identify affected products. 2. Fill out the Business Response Form and fax it to (11) 3030-1109 or return it to your local sales representative within 3 business days of receiving this notice, even if you do not have the product affected. Mention Event 5928. If you have any product to be returned, keep a copy of this form in your records. 3. To return the affected product, take a xerox copy of the completed Business Response Form, place it in the box along with your product, and attach the pre-printed shipping label and mail it to the company's local warehouse. 4. Share this information with all appropriate personnel in your facility. 5. As for any medical device, adverse reactions or quality problems, occurring in the use of this product, may be reported to the local representative.

Device

EXTRACT OF SURGICAL CLAMPS PROXIMATE * - Record 10132590054 - Lots Affected - See annex .. http:/...

Manufacturer

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