Events

Alerta De Seguridad para clinical tempspan cmt

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

¿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
    2012-08-29
  • Fecha de publicación del evento
    2012-08-29
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120829a.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: pentron clinical tempspan cmt medical device manufacturer, pentron clinical, has issued a medical device safety alert concerning tempspan cmt [part no. n69ca]. the manufacturer would also like to inform users that the current directions for use (dfu) for tempspan cmt lists a working time specification that is not indicative of the actual performance of the product. the current dfu lists the minimum working time as 60 seconds; however, the following timing parameters should be followed when using tempspan cmt there are no safety or efficacy concerns associated with tempspan cmt as the product will set. product tempspan cmt minimum working time 45 seconds maximum intra oral setting time (from initial mix) 3 minutes according to the manufacturer, the affected products were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 29 august 2012.

Device

clinical tempspan cmt
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Pentron Clinical TempSpan CMT
  • Manufacturer
    Pentron Clinical

Manufacturer

Pentron Clinical