Events

Retiro De Equipo (Recall) de Device Recall iovera

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 Myoscience 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
    65542
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1781-2013
  • Fecha de inicio del evento
    2013-06-21
  • Fecha de publicación del evento
    2013-07-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-07-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119527
  • 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
    Device, surgical, cryogenic - Product Code GXH
  • Causa
    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.
  • Acción
    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
  • Modelo / Serial
    Serial Numbers: 100100, 100101, 100103
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US distribution including CA and ID.
  • Descripción del producto
    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
  • Dirección del fabricante
    Myoscience Inc, 1600 Seaport Blvd Suite 450, Redwood City CA 94063-5563
  • Empresa matriz del fabricante (2017)
    MyoScience Inc.
  • Source
    USFDA