Events

Retiro De Equipo (Recall) de miraDry System consisting of the MD4000-MC Console, the MD4000-HP miraDry Handpiece, and the MD4000-BT miraDry bioTip and accessories. || General and Plastic Surgery: The miraDry System is intended for the treatment of primary axillary hyperhidrosis and was recently cleared for the permanent removal of underarm hair.

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 Miramar Labs, 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
    72386
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0234-2016
  • Fecha de inicio del evento
    2015-10-09
  • Fecha de publicación del evento
    2015-11-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-12-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140877
  • 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
    Instrument for treatment of hyperhidrosis - Product Code OUB
  • Causa
    Update to labeling for the miradry console to remind users to only use approved lubricants in a thin layer to prevent potential burns and blisters.
  • Acción
    Miramar Labs sent Medical Device Correction letters to all users on October 9, 2015 to inform them of the labeling clarification by UAPS First Class Certified mail or courier such as Federal Express. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed that the firm added a new warning to their labeling. The firm included an updated copy of the MD4000-MC User Manual with the new warning included and asked that customers destroy their older copy. Customers with questions were instructed to call Customer SService at 1-855-647-2379 or email info@miraDry.com

Device

miraDry System consisting of the MD4000-MC Console, the MD4000-HP miraDry Handpiece, and the MD40...
  • Modelo / Serial
    MN-MD4000-MC, all units
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    miraDry System consisting of the MD4000-MC Console, the MD4000-HP miraDry Handpiece, and the MD4000-BT miraDry bioTip and accessories. || General and Plastic Surgery: The miraDry System is intended for the treatment of primary axillary hyperhidrosis and was recently cleared for the permanent removal of underarm hair.
  • Manufacturer
    Miramar Labs, Inc.

Manufacturer

Miramar Labs, Inc.
  • Dirección del fabricante
    Miramar Labs, Inc., 2790 Walsh Ave, Santa Clara CA 95051-0963
  • Empresa matriz del fabricante (2017)
    Sientra Inc.
  • Source
    USFDA