Events

Rappel de AdVance Male Sling System

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par American Medical Systems, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    63540
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0259-2013
  • Date de mise en oeuvre de l'événement
    2012-10-19
  • Date de publication de l'événement
    2012-11-07
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-04-11
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114175
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Mesh, surgical, polymeric - Product Code FTL
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    Part # Lot/Serial Range  720088-01 722022001 to 796127002 720088-02 722024001 to 790266012 72404224 742528001 to 795689010
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    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.
  • Description du dispositif
    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.
  • Adresse du fabricant
    American Medical Systems, Inc., 10700 Bren Rd W, Minnetonka MN 55343-9679
  • Source
    USFDA