Events

Absorbent Dressings 의 안전성 경고

National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는 Colombia 에서 Covidien Llc. 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
    R1704-131
  • 사례 연번
    2009DM-0004710
  • 날짜
    2017-04-07
  • 사례 국가
    Colombia
  • 사례 출처
    INVIMA
  • 사례 출처 URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=94
  • 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 states that it has detected the possibility that sterile packaging is compromised, the use of products with this condition may increase the risk of infection, leading to possible adverse events on the patient.

Device

Absorbent Dressings
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Primary dressing for slow drainage wounds such as surgical sites, skin tears or poorly draining wounds. Indicated to cover a wound, give or withstand a moist wound environment, and allow the exchange of gases such as oxygen and water vapor to through the device. Surgical incisions, lacerations, central and peripheral line sites, pressure ulcers, stasis ulcers, arterial ulcers, diabetic ulcers, abrasions and donor areas. Lacerations or eye injuries. Used to absorb fluids and secretions in procedures such as postalaparotomy, tumors, infected wounds, chronic wounds, wounds with high exudate and premature rupture of membranes, among others. Primary dressing in arms and legs, secondary dressing in abdomen.
  • Manufacturer
    Covidien Llc.

Manufacturer

Covidien Llc.
  • 제조사 모회사 (2017)
    Medtronic plc
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    NIDFSINVIMA