Events

Alerta De Seguridad para ENDOLOOP Product Code EH496

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
    2016-04-18
  • Fecha de publicación del evento
    2016-04-18
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160418b.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 endoloop product code eh496 medical device manufacturer, ethicon, has issued a medical device safety alert concerning its endoloop product code eh496. this involves all the batches of endoloop product code eh496 manufactured since 2010. during ongoing stability testing, it was determined the average knot pull tensile strength in some of the batches was below the specification limit. however, the potential safety risks due to such below average knot pull tensile strength are mitigated by the fact that all the individual strands that were tested met the minimum values of knot pull tensile strength. according to the manufacturer, no complaints related to infection or any wound dehiscence has been reported from the batches manufactured with these casings. product recall is on-going. 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 18 april 2016.

Device

ENDOLOOP Product Code EH496
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Ethicon ENDOLOOP Product Code EH496
  • Manufacturer
    Ethicon

Manufacturer

Ethicon