Events

KIT CONFIDENCE PLUS - Kit Confidence Plus (11 cc) - Record no. 80145901323, lots: HPBB2B, HPBB2G, HPCB7B, HPDBGY, HPDBBL. 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
    1266
  • 날짜
    2013-04-22
  • 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
    If the devices have been transferred to other organizations, we ask that you provide the organization's name and contact information on the Field Correction Confirmation Form and forward a copy of this Field Security Notification to the organization to which the device was transferred. If you have further questions or concerns about the information contained in this Field Safety Notice, please contact the representative.
  • 원인
    The company informs that during the injection of cement, water in the hydraulic pump leaks into the pump body after passing through the piston, resulting in loss of pressure and inability to continue to inject cement. this may result in delayed surgery to prepare another kit or to close the procedure earlier than intended, which could result in the patient having to undergo additional anesthesia as a result of another surgical procedure.
  • 조치
    The company requests that the above-described combinations of product code and batch number be removed from service and contact your DePuy Synthes Spine * representative to arrange product return, credit and / or replacement. They further request that this information be distributed to relevant personnel in the services, including surgeons who may have received the product, the subject of this notification. See Letter to the Client at: http: //portal.anvisa.gov.br/wps/wcm/connect/4d1748804ff803369991ff6d6e8afaaa/KIT_CONFIDENCE_PLUS_FORMULARIO_DE_CONFIRMACAO_2_.pdf? MOD = AJPERES

Device

KIT CONFIDENCE PLUS - Kit Confidence Plus (11 cc) - Record no. 80145901323, lots: HPBB2B, HPBB2G,...

Manufacturer

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