Alerta De Seguridad para Cook Bush SL Ureteral Illuminating Catheter Set and Cook Bush DL Ureteral Illuminating Catheter Set

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Cook Medical.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2017-03-08
  • Fecha de publicación del evento
    2017-03-08
  • País del evento
  • Fuente del evento
    DH
  • URL de la fuente del evento
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: cook medical cook bush sl ureteral illuminating catheter set and cook bush dl ureteral illuminating catheter set medical device manufacturer, cook medical, has issued a medical device safety alert concerning its cook bush sl ureteral illuminating catheter set and cook bush dl ureteral illuminating catheter set as below: cook bush sl ureteral illuminating catheter set catalog identifier (part number): 084100 (g16745), 084120 (g16746) and j-bics-058020 (g16737) cook bush dl ureteral illuminating catheter set catalog identifier (part number): 084520 (g16747), 084510 (g16143) and j-bics-078000 (g16262) the manufacturer is initiating a voluntary recall of all lot numbers of the affected products. they have received an increased number of reports where the proximal black component that connects to the distal transparent component of the catheter may overheat and melt. there have been no reports of overheating along the transparent component of the catheter, which is the part of the device that comes into contact with the patient’s urethra, bladder, and ureter. according to the manufacturer, potential adverse events that may occur if these devices overheat and come into direct contact with skin include burns to the skin. the manufacturer advises users to examine inventory immediately to determine if they have the affected products. the affected products should be quarantined and returned to the manufacturer. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 8 march 2017.

Device

  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Cook Medical Cook Bush SL Ureteral Illuminating Catheter Set and Cook Bush DL Ureteral Illuminating Catheter Set
  • Manufacturer

Manufacturer