Events

Durex Extra Safe 12 Pack Condoms and Durex Fetherlite 12 Pack Condoms 에 대한 현장 안전성 서한

Health Products Regulatory Authority에 따르면, 해당 현장 안전성 서한 는 Ireland 에서 N/A 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
    SN2005(02)
  • 날짜
    2005-03-14
  • 사례 국가
    Ireland
  • 사례 출처
    HPRA
  • 사례 출처 URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/durex-extra-safe-12-pack-condoms-and-durex-fetherlite-12-pack-condoms&id=639af825-9782-6eee-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
    The two above specified batches of condoms bearing the durex brand name are counterfeit products that do not meet the requirements of the european standard for condoms.
  • 조치
    The IMB advises that you: Check both the outer packet and the condom foil to see if the details given above are the  same as those outlined on the product in your possession. If you have identified that you have product with the details above return any such affected product in your possession to your local pharmacy. If you think you may have used the affected condoms and have any health concerns, please consult your General Practitioner for their advice. Please be advised that this notice only applies to the 12 pack size of condoms specified above and not to any other pack size.

Device

Durex Extra Safe 12 Pack Condoms and Durex Fetherlite 12 Pack Condoms
  • 모델명 / 제조번호(시리얼번호)
    Product Name:        Durex Extra Safe 12 Pack Condoms Batch Number:        20602503 Expiry Date:            2007/11 Product Name:        Durex Fetherlite 12 Pack Condoms Batch Number:        VR3073 U / VR3073 C / VR3073 E / VR3073 € Expiry Date:            2008/02
  • 제품 설명
    Durex Extra Safe 12 Pack Condoms and Durex Fetherlite 12 Pack Condoms
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    HPRA