Events

Alerta De Seguridad para Correct Plus Bite Superfast

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

¿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
    2012-07-11
  • Fecha de publicación del evento
    2012-07-11
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120711a.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: kimberly-clark ultra fabric reinforced surgical gown x-large, sterile medical device manufacturer, pentron clinical issued a medical device safety alert concerning correct plus bite superfast. the affected part numbers are q34ia and q34ic. according to the manufacturer, the current directions for use (dfu) for correct plus bite superfast lists a working time that is not indicative of the actual performance of the product. the current dfu lists the total working time as 25 seconds, while the material actually provides a minimum working time of 15 seconds as outlined in the chart below: the manufacturer explained that there are no safety or efficacy concerns associated with correct plus bite superfast. for details, please refer to the attachment. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 11 july 2012.

Device

Correct Plus Bite Superfast
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Pentron Clinical Correct Plus Bite Superfast
  • Manufacturer
    Kimberly-Clark

Manufacturer

Kimberly-Clark