Events

Device Recall Penile Prosthesis 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 American Medical Systems 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
    49376
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2461-2008
  • 사례 시작날짜
    2008-07-17
  • 사례 출판 날짜
    2008-09-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-05-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73227
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Penile inflatable implant. - Product Code JCW
  • 원인
    The carton labeling does not match the product packaged inside. the package indicated that the device is an 18cm preconnected ms pump while it is actually an 18cm ultrex preconnected ms pump.
  • 조치
    On July 17, 2008, the physician who implanted the device received a phone call from AMS to discuss the event and be sure he understands what went wrong (Ultrex cylinders implanted instead of CX) and any new risks introduced to his patient so he can properly assess any impact it may have. A follow up letter " AMS Important Product Recall" dated July 21, 2008 was also sent to document the event and the call. The letter requested to return of the "Recall Acknowledgement Form". The second physician (tried not used) has already returned the device and will not receive further communication. A complaint was assigned to document the event.

Device

Device Recall Penile Prosthesis
  • 모델명 / 제조번호(시리얼번호)
    Lot # 551668
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    LA
  • 제품 설명
    AMS 700 CX MS Pump IZ, Preconnect Penoscrotal, 18 cm, Sterile EO, REF 72404232, Lot 551668001. Expiration Date 2010-Jun-20, Manufacture Date 2008 Jun 20.
  • Manufacturer
    American Medical Systems

Manufacturer

American Medical Systems
  • 제조사 주소
    American Medical Systems, 10700 Bren Rd W, Minnetonka MN 55343-9679
  • Source
    USFDA