Events

Alerta De Seguridad para PERMA-HAND Silk Suture

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

¿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
    2017-01-27
  • Fecha de publicación del evento
    2017-01-27
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170127.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: ethicon perma-hand silk suture medical device manufacturer, ethicon, has issued a medical device safety alert concerning its perma-hand silk suture (also referred to as mersilk silk suture) [product code: w584; lot number: jcq247]. the manufacturer has initiated a voluntary medical device removal of one lot of ethicon perma-hand silk suture. product from the affected lot was found to have an open sterile packaging seal which could compromise device sterility. at this time, the manufacturer has received no reports of adverse events for this issue. according to the manufacturer’s health hazard evaluation, there is an extremely rare probability of adverse consequences in patients in whom these sutures were used. healthcare practitioners that have treated patients using product from the affected lots should continue to follow those patients in the usual manner. 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 27 january 2017.

Device

PERMA-HAND Silk Suture
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: ETHICON PERMA-HAND Silk Suture
  • Manufacturer
    ETHICON

Manufacturer

ETHICON