Events

Retiro De Equipo (Recall) de Device Recall GMD UNIVERSAL URINARY INCONTINENCE SLING

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 Generic Medical Devices.

¿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
    56670
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1390-2011
  • Fecha de inicio del evento
    2011-02-14
  • Fecha de publicación del evento
    2011-02-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-09-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94212
  • 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
    Protective sheath sticks to itself and sleeve breakage has resulted in complaints and mdrs.
  • Acción
    The firm, GMD, issued an "URGENT MEDICAL DEVICE RECALL" letter dated February 14, 2011 to all customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed not to use any GMD Model 1010 Universal Slings remaining in their inventory; return any Model 1010 slings in their possession to the Distributors or GMD; notify their customers to whom they shipped Model 1010s of this voluntary recall and request them to return any Model 1010 slings in their possession to them; and return all Model 1010 inventories to GMD using the attached Recalled Model 1010 Return Form. Note: Full credit in the amount of the returned products purchase price will be issued for all sterile, unexpired product returned to GMD. Contact the GMD Product Performance Senior Manager, at phone: (253) 853 3512 or email: 1010recall@gmd-us.com, if you have any questions/issues related to this recall.

Device

Device Recall GMD UNIVERSAL URINARY INCONTINENCE SLING
  • Modelo / Serial
    All model number 1010 Universal Sleeved Slings. It cannot be determined whether each Sling is identified by an individual serial number.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide distribution: USA and countries including: Australia, Argentina, Brazil, Canada, South Africa, and Scandinavia.
  • Descripción del producto
    The GMD UNIVERSAL URINARY INCONTINENCE SLING (Code 1010) is supplied sterile and is intended for single patient use only. || The GMD Universal Sling is a sterile, single use device for the treatment of female stress urinary incontinence. It is comprised of a polypropylene sheath with a disposable universal low density polyethylene sleeve at each end of attachment of the sling to GMD's single use or reusable trocars. The universal sleeve has three trocar insertion points, the distal and proximal trocar insertion points are for inside-out, bottom-up approaches and a sleeve end trocar insertion point is for outside-in, top-down approaches. The design allows the physician to utilize the device for placement of a polypropylene mesh at the urethra or bladder neck.
  • Manufacturer
    Generic Medical Devices

Manufacturer

Generic Medical Devices
  • Dirección del fabricante
    Generic Medical Devices, 5727 Baker Way Nw Ste 201, Gig Harbor WA 98332-5811
  • Empresa matriz del fabricante (2017)
    Generic Medical Devices Inc.
  • Source
    USFDA