Events

AdVance Male Sling System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 American Medical Systems, Inc. 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
    63540
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0259-2013
  • 사례 시작날짜
    2012-10-19
  • 사례 출판 날짜
    2012-11-07
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-04-11
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114175
  • 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
    Mesh, surgical, polymeric - Product Code FTL
  • 원인
    American medical systems¿ (ams) is issuing a voluntary recall on a number of lots of the advance¿ male sling system (advance). ams has recently received a small number of complaints regarding the resorbable suture in the advance sling not lasting for the entire 15 month shelf life of the product. an internal investigation has been conducted and confirmed that some sutures degraded prior to the.
  • 조치
    American Medical Systems sent an "URGENT MEDICAL DEVICE RECALL" dated October 18, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The letter instructs customers to return any existing stock of the recall product and to complete and return the Product Recall Acknowledgment Form. Contact AMS Customer Service at 1-800-328-3881 for additional information or questions. .

Device

AdVance Male Sling System
  • 모델명 / 제조번호(시리얼번호)
    Part # Lot/Serial Range  720088-01 722022001 to 796127002 720088-02 722024001 to 790266012 72404224 742528001 to 795689010
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the countries of Austria, Australia, Brazil, Canada, Germany, Estonia, Spain, Finland, France, Great Britain, Hong Kong, Croatia, India, Morocco, Mexico, Malaysia, Netherlands, New Zealand, Panama, Poland, Russian Federation, Solomon Islands, Singapore, Thailand, Turkey, Venezuela, South Africa, Chile, Colombia, Costa Rica, Slovenia, Argentina, China, and Taiwan.
  • 제품 설명
    AMS AdVance" Male Sling System || 720088-01 AMS AdVance" Male Sling System (US) || 720088-02 AMS AdVance" Male Sling System (Intl) || 72404224 AMS Male TO Sling System (Intl). || The AMS AdVance Male Sling System is intended for the placement of a suburethral sling for the treatment of male stress urinary incontinence (SUI).
  • Manufacturer
    American Medical Systems, Inc.

Manufacturer

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