Events

Rappel de Device Recall CQUR TacShield Mesh

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 Atrium Medical Corporation.

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
    65698
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1939-2013
  • Date de mise en oeuvre de l'événement
    2013-07-19
  • Date de publication de l'événement
    2013-08-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-03-18
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119926
  • 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
    Additional instructions for use and storage conditions as coated mesh can adhere to the inner packaging liner due to exposure to high humidity conditions.
  • Action
    Atrium Medical issued Recall Letter via UPS and e-mail on 7/19/13 to the accounts and field representatives. The notification identifies the problem, product, and risk factors. If the Product is exposed to excessive humidity for an extended period of time, then the increased humidity occurring inside the pouch can potentially cause the coating on the mesh to strongly adhere to the inner handling sleeve. A reply for is requested to be completed to acknowledge receipt to the notification. Additional language to the instructions for use (IFU) to include: Prolonged exposure to high humidity may result in increased rate of adherence of the C-QUR mesh to its handling sleeve. Store in a Controlled Room Temperature (25 C / 77 F ) or less. Brief exposure to up to 40 C (104 F ) is acceptable. Questions please contact Atrium Medical Customer Service at 1- 800- 528-7486 Monday through Friday 9:00 am to 5:00 pm EDT.

Device

Device Recall CQUR TacShield Mesh
  • Modèle / numéro de série
    Product lines with lot number 10405513 and higher
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    USA (nationwide) including Puerto Rico and the countries of Australia Austria Bahrain Brazil Canada Chile Colombia Dominican Republic Ecuador El Salvador France Germany Great Britain Greece Honduras Hong Kong India Ireland Israel Italy Japan Jordan Korea Malaysia Mexico Netherlands New Zealand Nicaragua Norway Panama Peru Portugal Romania Saudi Arabia Singapore South Africa Spain Sri Lanka Switzerland Taiwan Thailand Turkey and Venezuela.
  • Description du dispositif
    C-QUR TacShield Mesh (All sizes and shapes). || Intended for use in soft tissue deficiencies.
  • Manufacturer
    Atrium Medical Corporation

Manufacturer

Atrium Medical Corporation
  • Adresse du fabricant
    Atrium Medical Corporation, 5 Wentworth Dr, Hudson NH 03051-4929
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    USFDA