Events

Retiro De Equipo (Recall) de PERITONEAL DIALYSIS SWAN NECK CATHETERS

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por MEDIONICS INTERNATIONAL 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
    154448
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2014-11-05
  • 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
    Medionics has received a few reports of opacification and ballooning of the peritoneal dialysis catheters at the exit-site however no adverse events have been reported associated with this issue.The age of the implanted catheters in the reported incidents ranged from 30 months to 80 months. investigation of these incidents indicates that the structural changes to pd catheters at the exit-site may occur with prolonged use of certain cleansing agents and antibiotic cream or ointment. additionally use of solutions containing organic solvents for catheter cleaning may cause the breakdown of silicone tubing. the likelihood of structural changes to silicone pd catheters increases over the duration of implantation.

Device

PERITONEAL DIALYSIS SWAN NECK CATHETERS
  • Modelo / Serial
    Model Catalog: SNCA5262L (Lot serial: All Lots. Contact Mfg)
  • Descripción del producto
    PERITONEAL DIALYSIS SWAN NECK CATHETERS
  • Manufacturer
    MEDIONICS INTERNATIONAL INC.

Manufacturer

MEDIONICS INTERNATIONAL INC.