Events

peripheral systems of self-expanding nitinol stents pulsar-18 and pulsar-35, with a stent length of 200 mm 에 대한 현장 안전성 서한

Office for Registration of Medicinal Products, Medical Devices and Biocidal Products에 따르면, 해당 현장 안전성 서한 는 Poland 에서 Biotronic AG 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 ID
    1436
  • 날짜
    2015-06-10
  • 사례 국가
    Poland
  • 사례 출처
    ORMPMDBP
  • 사례 출처 URL
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-biotronic-ag-dotycz%C4%85ca-wycofania-z-obrotu-i-u%C5%BCywania-niekt%C3%B3rych-partii
  • 비고 / 경고
    Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 Poland.
  • 데이터 추가 비고
  • 조치
    Biotronic AG safety notice regarding the withdrawal and use of some batches of peripheral systems of self-expanding nitinol stents Pulsar-18 and Pulsar-35, with a stent length of 200 mm

Device

peripheral systems of self-expanding nitinol stents pulsar-18 and pulsar-35, with a stent length ...
  • 모델명 / 제조번호(시리얼번호)
  • Manufacturer
    Biotronic AG

Manufacturer

Biotronic AG
  • 제조사 모회사 (2017)
    Ms Holding Ii Se
  • 제조사 의견
    Biotronik told ICIJ that, when it identifies the need to issue a recall, the company immediately informs physicians of all potentially affected patients. It also noted that product recalls for all manufactures are publically available on the relevant national authorities’ websites. “As soon as an event is deemed serious either by a hospital or a manufacturer, it is reported inter alia to the regulatory authority in the country in which the incidence has occurred, as well as to the FDA for US-approved devices, even if the event has occurred outside of the US,” the company said.
  • Source
    ORMPMDBP