Events

Retiro De Equipo (Recall) de LGX PRECONNECT WITH MS PUMP INFRAPUBIC INHIBIZONE COATED

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por AMERICAN MEDICAL SYSTEMS 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
    20917
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-07-23
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    Reports from physicians and/or patients with difficulty inflating ams 700 with ms pump cylinders. this occurred either during srugical implantation or post-operatively.

Device

LGX PRECONNECT WITH MS PUMP INFRAPUBIC INHIBIZONE COATED
  • Modelo / Serial
    Model Catalog: 72404259 (Lot serial: all); Model Catalog: 72404280 (Lot serial: all); Model Catalog: 72404257 (Lot serial: all); Model Catalog: 72404256 (Lot serial: all); Model Catalog: 72404255 (Lot serial: all); Model Catalog: 72404209 (Lot serial: all); Model Catalog: 72404303 (Lot serial: all); Model Catalog: 72404302 (Lot serial: all); Model Catalog: 72404301 (Lot serial: all); Model Catalog: 72404300 (Lot serial: all); Model Catalog: 72404239 (Lot serial: all); Model Catalog: 72404238 (Lot serial: all); Model Catalog: 72404237 (Lot serial: all); Model Catalog: 72404236 (Lot serial: all); Model Catalog: 72404235 (Lot serial: all); Model Catalog: 72404289 (Lot serial: all); Model Catalog: 72404288 (Lot serial: all); Model Catalog: 72404287 (Lot serial: all); Model Catalog: 72404286 (Lot serial: all); Model Catalog: 72404285 (Lot serial: all); Model Catalog: 72404269 (Lot serial: all); Model Catalog: 72404268 (Lot serial: all); Model Catalog: 72404267 (Lot serial: all); Model Catalog: 72404266 (Lot seria
  • Descripción del producto
    LGX PRECONNECT WITH MS PUMP INFRAPUBIC WITH INHIBIZONE
  • Manufacturer
    AMERICAN MEDICAL SYSTEMS INC

Manufacturer

AMERICAN MEDICAL SYSTEMS INC
  • Dirección del fabricante
    MINNETONKA
  • Source
    HC