Events

Alerta De Seguridad para PREMISA Unidose Refills - A3.5

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

¿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
    2017-02-02
  • Fecha de publicación del evento
    2017-02-02
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170202.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: kerr corporation premisa unidose refills - a3.5 medical device manufacturer, kerr corporation, has issued a medical device safety alert concerning its premisa unidose refills - a3.5 (part number: 32814; lot number: 5641195; shipped between november 2015 to december 2015) it has recently come to the manufacturer’s attention that an issue with the production process used to package the affected lots of premisa may lead to the presence of plastic particulates in the dental composite material. the particulate is visible to doctors and should be easy to remove prior to or even after curing. furthermore, the particulate is unlikely to cause any adverse health consequences. there is no need to replace any restorations placed with this material. product recall and replacement is on-going. according to the manufacturer, 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 2 february 2017.

Device

PREMISA Unidose Refills - A3.5
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Kerr Corporation PREMISA Unidose Refills - A3.5
  • Manufacturer
    Kerr Corporation

Manufacturer

Kerr Corporation