Events

Retiro De Equipo (Recall) de MiniArc Pro Single incision Sling System

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 Astora.

¿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
    72552
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0279-2016
  • Fecha de inicio del evento
    2015-10-26
  • Fecha de publicación del evento
    2015-11-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-03-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141509
  • 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
    mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, mini-sling - Product Code PAH
  • Causa
    The lot number on the outer carton label did not match the lot number printed on the tray label or identification labels inside the box. the identification labels inside the box are placed on medical records and other documents associated with the procedure. use of incorrectly identified labels may prevent direct traceability of the implanted unit in the future.
  • Acción
    Consignees were hand delivered by sales representatives a Astora Women's Health "Urgent Recall Notice". The letter was addressed to Physician, Health Care Professional, Nurse & Risk Manager. The letter described the problem and the product involved in the recall. Consignees were advised to check their inventory and return all affected product, notify those that might be affected and to complete and return the Acknowledgement Form. For questions contact ASTORA Women's Health Customer Service at 1-844-879-0787.

Device

MiniArc Pro Single incision Sling System
  • Modelo / Serial
    Lot number 936405. Serial numbers 936405001 through 936405056
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Distributed in the states of AZ, CA, DE, IL, KS, NE, NJ, NY, OH, PA, TX
  • Descripción del producto
    MiniArc Pro Single incision Sling System, Model number / Product Reference 9000261, Lot 936405xxx. Designed to treat female stress urinary incontinence.
  • Manufacturer
    Astora

Manufacturer

Astora
  • Dirección del fabricante
    Astora, 13200 Pioneer Trl, Eden Prairie MN 55347-4119
  • Source
    USFDA