Events

INSTAT MCH HEMOSTATIC MICROFIBRILLARY COLLAGEN, Model 1984 and 1985, Registration no. 80145900849, lots: 1110786, 1110228, 1110227, 1110785, 1110232, 1105179. 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
    1267
  • 날짜
    2013-04-23
  • 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 higher levels of endotoxin may result in fever in the immediate postoperative period. At this time the company is not aware of reports of patient injury or other adverse events in relation to these batches of products. However, it advises that if the service has already implanted or used the collagen sponges affected by this recall, the patient is monitored for fever in the immediate postoperative period according to the standard hospital or clinical protocol.
  • 원인
    The registrant reports that integra lifesciences has detected through a quality assurance review that some of the processes may have deviated from the production process during the manufacture of specific batches of the product. batches of the product in question have been approved in all tests for finished products, are sterile and have been tested and accepted for endotoxin levels. however, due to process drift, they may have been released with higher levels of endotoxin than allowed by product specifications. according to the company's assessment, higher levels of endotoxin may result in fever in the immediate postoperative period. we are not aware of reports of patient injuries or other adverse events in relation to these batches of products.
  • 조치
    1. Make sure you have some of the batches listed on the next page and if so, stop using the product. 2. Remove the service product. 3. Complete the Return Confirmation Form and send this form to the representative. 4. The Customer Service department will contact you for return and replacement of the product. See Letter to the Client at: http: //portal.anvisa.gov.br/wps/wcm/connect/98287d004ff8045699a4ff6d6e8afaaa/Carta_ao_cliente_Instat_MCH.pdf? MOD = AJPERES

Device

INSTAT MCH HEMOSTATIC MICROFIBRILLARY COLLAGEN, Model 1984 and 1985, Registration no. 80145900849...

Manufacturer

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