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
    69796
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0806-2015
  • Date de mise en oeuvre de l'événement
    2014-10-15
  • Date de publication de l'événement
    2014-12-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-05-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131554
  • 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, for stress urinary incontinence, male - Product Code OTM
  • Cause
    During routine periodic packaging testing, ams identified that in simulated extreme shipping and handling situations the sterile barrier packaging of the needle passer components supplied with the advance" male sling system; model # 720088-01; advance" xp male sling system; model # 720163-01; monarc" c subfacial hammock; model # 72404195; monarc" + subfacial hammock; model #.
  • Action
    Consignees were sent an AMS "Urgent Recall Notice" dated October 15, 2014. The letter was addressed to Physician, Health Care Professional, Nurse and Risk Manger. The letter described the problem and the product involved in the recall. Requested consignees to return all affected product and to complete and return the Acknowledgement Form. For questions, they can contact American Medical Systems Customer Service at 1-800-328-3881 (x6469). A second letter was available as optional communication to implanting physicians known by AMS to be regular users of the device. This physician letter was dated October 20, 2014.

Device

AdVance"Male Sling System
  • Modèle / numéro de série
    REF 720088-01 Lot/Serial # 878849001 to 904928030 REF 720163-01 Lot/Serial # 767189001 to 905578100
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution-US (nationwide) including DC and Puerto Rico and the countries of AUSTRIA, BELGIUM, CROATIA, CECH REPUBLIC, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, IRELAND, ISRAEL, ITALY, LEBANON, NETHERLANDS, NORWAY, POLAND, PORTUGAL, SAUDI ARABIA, SLOVENIA, SERBIA, SOUTH AFRICA, SPAIN. SWEDEN, SWITZERLAND, TURKEY, UNITED KINGDOM, CHILE, COLUMBIA, COSTA RICA, HONG KONG, MALAYSIA, MARTINIQUE, NEW ZEALAND, PANAMA, PHILIPPINES, SINGAPORE, THAILAND, VENEZUELA, CANADA, AUSTRALIA.
  • Description du dispositif
    AdVance"Male Sling System, REF 720088-01 & || AdVance" XP Male Sling System REF 720163-01 || (not commercially available in the US) || The AdVance Male Sling System consists of two, sterile single-use surgical instruments called helical needle passers and a mesh sling with attached connectors. One end of each helical needle passer is keyed to allow a secure attachment of the sling connectors. The sling mesh is constructed of polypropylene monofilament mesh that is precut to 1.2 centimeters arm width, 3.55 centimeters center width, and 35.5 centimeters length. Two absorbable tensioning sutures are threaded into the length of the mesh. Plastic sheaths are placed over each arm of the mesh to aide in ease of placement. The connectors are attached to the ends of the helical needle passers during the procedure. The mesh and suture portions of the sling are intended to remain in the body as a permanent implant and the mesh component is not absorbed or degraded by the action of tissue in-growth or tissue enzymes.
  • 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