MEROCEL SURGICAL PATTIES 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 MEDTRONIC OF CANADA LTD. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    30395
  • 사례 위험등급
    II
  • 사례 시작날짜
    2017-09-14
  • 사례 국가
  • 사례 출처
    HC
  • 비고 / 경고
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • 데이터 추가 비고
  • 원인
    As part of a notification to all manufacturers of neurosurgical patties medtronic xomed was informed by the food and drug administration's (fda) center for devices and radiological health (cdrh) of a potential postmarket safety concern associated with the use of neurosurgical patty devices. the potential safety concern identified by the fda "is related to clinical consequences when some patties which are designed to be x-ray detectable or radiopaque to assist with post-procedural removal in the event of a missing device are not visible during x-ray imaging." to address this potential concern medtronic is including additional information in the instructions for use regarding these issues to further clarify the use of these devices to health care practitioners. the updated instructions for use includes the precautions that will help reduce the potential for clinical consequences when some neurosurgical patties which are designed to be x ray detectable or radiopaque to assist with post-procedural removal in the event of a missing device are not visible during x-ray imaging.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 300507 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 300506 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 300505 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 300503 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 300501 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 80-04009 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 80-04008 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 80-04007 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 80-04006 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 80-04005 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 80-04004 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 80-04003 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 80-04002 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 80-04001 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 80-04000 (Lot serial: > 10 lot numbers contact mfg); Model Catalog
  • 제품 설명
    MEROCEL SURGICAL PATTIES;NEURAY SURGICAL PATTIES;NEURAY SURGICAL STRIPS
  • Manufacturer

Manufacturer

  • 제조사 주소
    BRAMPTON
  • 제조사 모회사 (2017)
  • 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
    HC