Events

Non-sterile Boston Scientific Endoscopy and Urology / Women’s Health Devices Stolen 에 대한 현장 안전성 서한

Health Products Regulatory Authority에 따르면, 해당 현장 안전성 서한 는 Ireland 에서 Boston Scientific Corporation 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Field Safety Notice
  • 사례 연번
    SN2011(08)
  • 날짜
    2011-05-13
  • 사례 국가
    Ireland
  • 사례 출처
    HPRA
  • 사례 출처 URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/non-sterile-boston-scientific-endoscopy-and-urology-women-s-health-devices-stolen&id=0c87f825-9782-6eee-9b55-ff00008c97d0
  • 비고 / 경고
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
  • 데이터 추가 비고
  • 원인
    Stolen non-sterile boston scientific endoscopy and urology/women’s health products are labelled as “sterile”.
  • 조치
    The IMB advises that you:  • Check your inventory for the affected product  • Monitor all incoming shipments for the affected product  • If you have any of these identified devices in your current inventory or receive any future delivery of these batches of devices, do not use the devices and contact Boston Scientific  • If healthcare professionals suspect or know that the stolen non-sterile devices have been used, it is recommended that they monitor and treat patients accordingly.

Device

Non-sterile Boston Scientific Endoscopy and Urology / Women’s Health Devices Stolen
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Non-sterile Boston Scientific Endoscopy and Urology / Women’s Health Devices Stolen
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • 제조사 모회사 (2017)
    Boston Scientific
  • 제조사 의견
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    HPRA