RENASYS - G Kit with sterile gauze base 의 안전성 경고

National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는 Colombia 에서 Smith & Nephew Inc. 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
    R1608-321
  • 사례 연번
    2010DM-0005709
  • 날짜
    2016-08-02
  • 사례 국가
  • 사례 출처
    INVIMA
  • 사례 출처 URL
  • 비고 / 경고
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 recall data from the U.S. and Colombia.
  • 데이터 추가 비고
  • 원인
    The manufacturer reports that it has detected that the referenced devices may have the sterile barrier compromised, leading to its use may cause possible adverse events on patients.

Device

  • 모델명 / 제조번호(시리얼번호)
    66020933, 66020934, 66020935, 66020936, 66800394, 66800494, 66800495, 66800496, 66800497, 66800932, || 66800933, 66800934, 66800935, 66800936, 66801255, || 66801256, 66801257 and 66801258, specific lots.
  • 제품 설명
    The RENASYS - G Kit with sterile gauze base SMITH & NEPHEW. It is used in conjunction with the wound pressure treatment system to deliver a negative pressure to a wound site for the healing effects of the wound itself. The RENASYS - G: with sterile gauze base SMTTH & NEPHEW will be used with negative pressure system to deliver negative pressure in the wound. SMITH & NEPHEW NPWT system indicated for patients who will benefit from a suction device (negative pressure), since any promotion of wound healing through the elimination of liquid risk and body fluids, wound exudates and infectious material. NPWT is appropriate for use in the following types of injuries: chronic, acute, traumatic, sub-acute and dehiscence of wounds, ulcers (such as hypertension or ladiabetes). Partial thickness burns. flaps and grafts.
  • Manufacturer

Manufacturer