Events

Rappel de Device Recall iovera

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 Myoscience 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
    65542
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1781-2013
  • Date de mise en oeuvre de l'événement
    2013-06-21
  • Date de publication de l'événement
    2013-07-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-07-15
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119527
  • 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
    Device, surgical, cryogenic - Product Code GXH
  • Cause
    The outer box label of the product was labeled with a down revision label which did not include the us labeling requirements, specifically the symbol descriptors and also the "caution: federal law (usa) restricts this device to sale by or on the order of a physician." this product was previously labeled for eu distribution only.
  • Action
    Myoscience representatives visited both affected sites on June 14, 2013 and relabeled the product in person. Neither site had used the product and was unaffected by the relabeling. No formal communication was issued.

Device

Device Recall iovera
  • Modèle / numéro de série
    Serial Numbers: 100100, 100101, 100103
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US distribution including CA and ID.
  • Description du dispositif
    Myoscience brand iovera Smart Tip, Myoscience Cryo-Touch IV, a Cryogenic Surgical device, REF Catalog Number: STA0311-10. || Product Usage: || The Myoscience Cryo-Touch IV (a.k.a. iovera) is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. The Cryo-Touch IV (a.k.a. iovera) is not indicated for treatment of central nervous system tissue.
  • Manufacturer
    Myoscience Inc

Manufacturer

Myoscience Inc
  • Adresse du fabricant
    Myoscience Inc, 1600 Seaport Blvd Suite 450, Redwood City CA 94063-5563
  • Société-mère du fabricant (2017)
    MyoScience Inc.
  • Source
    USFDA