Events

Device Recall AMS 800 Urinary Control 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.

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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
    64875
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1280-2013
  • 사례 시작날짜
    2013-03-01
  • 사례 출판 날짜
    2013-05-10
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-04-24
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117227
  • 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
    Device, incontinence, mechanical/hydraulic - Product Code EZY
  • 원인
    American medical systems, inc. is initiating a recall on two components of the ams 800¿ urinary control system, control pump & pressure-regulating balloon. these products were released despite not meeting all final product release criteria.
  • 조치
    American Medical Systems sent two written communications distributed within the United States. The first is a letter that is being delivered to customers who purchased the affected lots using their ship to address from the original sales order. The second is a letter being delivered to implanting physician customers who are known by AMS to be regular users of the devices. Similar letters will be sent to international customers, including both end users and distributors (where applicable). American Medical Systems sent a "Urgent Medical Device Recall" letter dated February 28, 2013, to all affected customers. The letters identified the product, the problem, and the action needed to be taken by the customer. Customers were instructed to return the recalled product and to complete the Product Recall Acknowledgement Form. The letters addressed to "Physicians" advised consignees against prophylactic removal of implanted control pumps and pressure-regulating balloons contained within the scope of the product recall. For further questions please call AMS Customer Service at 1 (800) 328-3881

Device

Device Recall AMS 800 Urinary Control System
  • 모델명 / 제조번호(시리얼번호)
    Model # Lot #  72400024 771029003 72400024 794405011 72400024 744211005 72400024 794405007 72400024 744211008 72400024 771029001 72400024 794405006 72400024 771029005 72400024 744211009 72400024 771029016 72400023 741419006 72400024 794405001 72400024 794405002 72400024 794405004 72400024 794405005 72400024 794405015 72400024 794405016 72400024 744211001 72400024 744211004 72400024 800345007 72400024 800345014 72400024 771029012 72400024 794405009 72400024 794405012 72400024 794405013 72400024 794405014 72400023 741419004 72400023 741419005 72400023 741419007 72400023 741419009 72400023 741419010 72400024 744211002 72400024 744211003 72400024 744211006 72400024 744211007 72400024 744211010 72400024 744211011 72400024 771029002 72400024 771029004 72400024 771029006 72400024 771029007 72400024 771029008 72400024 771029009 72400024 771029010 72400024 771029011 72400025 803589003 72400024 771029014 72400024 771029015 72400025 803589005 72400024 794405003 72400024 771029013 72400024 794405008 72400024 800345008 72400024 794405010 72400024 800345001 72400024 800345003 72400024 800345004 72400024 800345005 72400024 800345006 72400024 800345009 72400024 800345010 72400024 800345012 72400024 800345015 72400024 800345002
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution -- Nationwide Distribution including the states of AL, AZ, AR, CA, CO, CT, DE, FL, GA, IL, IN, IA, KS, KY LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NH, NJ, NM, NY,NC, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VT, VA, WA and WI., and the countries of AUSTRIA, AUSTRALIA, CANADA, BELGIUM, SWITZERLAND, CZECH REPUBLIC, GERMANY, DENMARK, ESTONIA, SPAIN, FINLAND, FRANCE, GREAT BRITAIN, IRELAND, ITALY, LEBANON, NETHERLANDS, NORWAY, SWEDEN, TURKEY, ARGENTINA, BRAZIL, IVORY COST, COLOMBIA, ECUADOR, INDIA, JAPAN, MEXICO, NEW ZEALAND, PANAMA and VENEZUELA.
  • 제품 설명
    AMS 800¿ Urinary Control System. || The AMS 800¿ Urinary Control System is used to treat urinary incontinence due to reduced outlet resistance (intrinsic sphincter deficiency) following prostate surgery. The AMS 800¿ Urinary Control System is an implantable, fluid filled, solid silicone elastomer device used to treat stress urinary incontinence. It is designed to restore the natural process of urinary control. The device simulates normal sphincter function by opening and closing the urethra at the control of the patient. The AMS 800 system consists of three inter connected components: a cuff, a pump, and a pressure-regulating balloon. The three components are connected with kink-resistant tubing. The AMS 800 can be implanted at either the bulbous urethra or the bladder neck.
  • 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