Events

translation missing: ko.activerecord.attributes.event.titles.recall_field_safety_notice

Saudi Food & Drug Authority에 따르면, 해당 translation missing: ko.activerecord.attributes.event.types.recall_field_safety_notice 는 Saudi Arabia 에서 Aesculap 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
    Recall / Field Safety Notice
  • 사례 ID
    mdprc 094 04 18 000
  • 사례 시작날짜
    2018-04-22
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=12482
  • 비고 / 경고
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
  • 데이터 추가 비고
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • 원인
    The aesculap ag received feedback from the market that the plastic sleeves of a strauss penis clamp 130mm - ef401r had stuck together after reprocessing. during complaint investigation it has been determined that the plastic sleeves of the returned instrument do not meet the valid specification. instead of the specified material silicone, the material pvc was used for the manufacturing of the sleeves. this could render affected instruments unusable after reprocessing. internal investigation conducted at the manufacturing plant revealed that the reported failure can be limited to the production period from february 2016 to october 2017. a definite identification of an affected product is not possible without the help of suitable equipment. we therefore ask you to consider all of your existing strauss penis clamp 130mm - ef401r to be potentially affected. the results of investigation revealed that there is no increased risk expected for patients who have been treated with the affected product. according to our internal distribution information your facility received applicable unit/s manufactured within the above mentioned production period. we kindly ask you to check if an affected instrument is currently in use at your facility. in case you have located an affected product: please ensure that these instruments are no longer used.

Device

Surgical PENIS CLAMP
  • 모델명 / 제조번호(시리얼번호)
    EF401R
  • 제품 설명
    Surgical PENIS CLAMP
  • Manufacturer
    Aesculap

Manufacturer

Aesculap