Events

Rappel de VENTRIO HERNIA PATCH

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 Davol, Inc., Sub. C. R. Bard, 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
    55251
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1536-2010
  • Date de mise en oeuvre de l'événement
    2010-04-08
  • Date de publication de l'événement
    2010-05-04
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-10-27
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90418
  • 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
    Mislabeled: product labeled as small oval (3.1" x 4.7") may contain small circle (3.0").
  • Action
    An "URGENT RECALL: BARD VENTRIO SMALL OVAL HERNIA PATCH (LOT DATB0015" letter dated April 8, 2010, was issued by the firm (Davol) to all customers via FedEx overnight with signature required. The letter describes the product, problem and action to be taken by the customers. The customers were instructed to: please examine their inventory and immediately discontinue use of this lot; contact the Davol Customer Service Department at 1-800-556-6275 for instructions on how to return product to firm; complete and fax the EFFECTIVENESS CHECK sheet to 1-401-825-8753, and forward a copy of this letter, if they are a distributor, to their customers who have received the product and lot number. All products returned will be held at the Davol, Warwick location. Please contact your Davol Territory Manager or C.R. Bard's Medical Service Support Department at 1-800-562-0027 if you have any other questions.

Device

VENTRIO HERNIA PATCH
  • Modèle / numéro de série
    REF 0010211 Lot DATB0015
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide distribution
  • Description du dispositif
    Bard Ventrio Small Oval Hernia Patch 8cm X 12cm (3.1" x 4.7"), Warwick, RI || Product Code: 0010211 || The Ventrio Hernia Patch is a self-expanding non-absorbable, sterile prosthesis, containing two primary layers of monofilament polypropylene mesh stitched with PTFE monofilament to an ePTFE sheet, forming a positioning pocket. The Ventrio Hernia Patch is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias.
  • Manufacturer
    Davol, Inc., Sub. C. R. Bard, Inc.

Manufacturer

Davol, Inc., Sub. C. R. Bard, Inc.
  • Adresse du fabricant
    Davol, Inc., Sub. C. R. Bard, Inc., 100 Crossings Blvd, Warwick RI 02886-2850
  • Société-mère du fabricant (2017)
    Becton, Dickinson and Company
  • Source
    USFDA