Events

Retiro De Equipo (Recall) de AdVance Male Sling System

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por American Medical Systems, Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    63540
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0259-2013
  • Fecha de inicio del evento
    2012-10-19
  • Fecha de publicación del evento
    2012-11-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-04-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114175
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Mesh, surgical, polymeric - Product Code FTL
  • Causa
    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.
  • Acción
    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
  • Modelo / Serial
    Part # Lot/Serial Range  720088-01 722022001 to 796127002 720088-02 722024001 to 790266012 72404224 742528001 to 795689010
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    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.
  • Descripción del producto
    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.
  • Dirección del fabricante
    American Medical Systems, Inc., 10700 Bren Rd W, Minnetonka MN 55343-9679
  • Source
    USFDA