Events

Retiro De Equipo (Recall) de SHILEY DISPOSABLE CANNULA TRACHEOSTOMY TUBE

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por COVIDIEN LP - RESPIRATORY & MONITORING SOLUTIONS GBU.

¿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
    152895
  • Clase de Riesgo del Evento
    I
  • Fecha de inicio del evento
    2010-04-16
  • 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
    Manufacturer received customer reports of serious adverse health consequences that may be linked to certain cuffed shiley tracheostomy tubes in which the cuff does not hold air(leaks in the pilot balloon inflation assembly.

Device

SHILEY DISPOSABLE CANNULA TRACHEOSTOMY TUBE
  • Modelo / Serial
    Model Catalog: DCT (Lot serial: 0810002426 TO 0908000766 4DCT); Model Catalog: PERC (Lot serial: 0810002426 TO 0908000766 4DCT); Model Catalog: MDCT (Lot serial: 0812000028 TO 0908000232); Model Catalog: PERC (Lot serial: 0812000028 TO 0908000232); Model Catalog: DFEN (Lot serial: 0812000028 TO 0908000232); Model Catalog: DCT (Lot serial: 0812000028 TO 0908000232); Model Catalog: MDCT (Lot serial: FOR 10DFEN :); Model Catalog: PERC (Lot serial: FOR 10DFEN :); Model Catalog: DFEN (Lot serial: FOR 10DFEN :); Model Catalog: DCT (Lot serial: FOR 10DFEN :); Model Catalog: MDCT (Lot serial: 0911000199 TO 0911000221 MDCT); Model Catalog: PERC (Lot serial: 0911000199 TO 0911000221 MDCT); Model Catalog: DFEN (Lot serial: 0911000199 TO 0911000221 MDCT); Model Catalog: DCT (Lot serial: 0911000199 TO 0911000221 MDCT); Model Catalog: MDCT (Lot serial: 0810002453 TO 0908000797 8PERC); Model Catalog: PERC (Lot serial: 0810002453 TO 0908000797 8PERC); Model Catalog: DFEN (Lot serial: 0810002453 TO 0908000797 8PERC); Model C
  • Clasificación del producto
    Anesthesiology Devices
  • Descripción del producto
    SHILEY DISPOSABLE CANNULA TRACHEOSTOMY TUB
  • Manufacturer
    COVIDIEN LP - RESPIRATORY & MONITORING SOLUTIONS GBU

Manufacturer

COVIDIEN LP - RESPIRATORY & MONITORING SOLUTIONS GBU
  • Dirección del fabricante
    BOULDER
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    HC