Events

Alerta De Seguridad para Askina Gel and Calgitrol Paste

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

¿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
    2018-05-02
  • Fecha de publicación del evento
    2018-05-02
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180502a.html
  • 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: b. braun hospicare ltd askina gel and calgitrol paste medical device manufacturer, b. braun hospicare ltd., has issued a medical device safety alert concerning its askina gel and calgitrol paste [article number: 14291, 001419n, 001419nru, 001419s, 001419sbr, 001419ses, 001419sescp, 001419sf, 001419sfr, 001419sru, 6241001, 6241505, 6241505f, 6241510, 6242501, 6242501fr, 6245001]. in the manufacturing site, it was determined that the irradiation dose qualified for sterilization of the above mentioned products was too low. in consequence, the germ reduction through gamma irradiation may not have reached the requested sterility assurance level of 10-6. the effect cannot be limited to specific batches. according to the manufacturer, there was no market feedback on any adverse patient outcome which could be associated to the above described observation. however, the manufacturer decided to recall the affected products from the market as a preventive measure. the affected users are asked to take the following actions: identify and quarantine the affected devices; do not use affected devices anymore; patients with affected devices in use should be monitored carefully. if clinically uneventful, an exchange of the product is not indicated. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 2 may2018.

Device

Askina Gel and Calgitrol Paste
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: B. Braun Hospicare Ltd Askina Gel and Calgitrol Paste
  • Manufacturer
    B

Manufacturer

B