Events

Alerta De Seguridad para bipolar temporary myocardial heartwire

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

¿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
    2012-11-28
  • Fecha de publicación del evento
    2012-11-28
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20121128.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: oscor bipolar temporary myocardial heartwire the health canada has posted a medical device safety alert concerning bipolar temporary myocardial heartwire (model no.: tme 64-s; lot/serial no.: c1-07056) manufactured by oscor inc. according to the health canada, spacing between zig-zag wire and insulation is too long (10mm instead of 2mm). the defect affects the proper placement of zig-zag into the heart wall and subsequent electrical contact might be compromised. for details, please refer to the health canada website: http://www.Hc-sc.Gc.Ca/dhp-mps/compli-conform/recall-retrait/ _list/rec-ret_md-im_date_oct-dec_2012-eng.Php if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 28 november 2012.

Device

bipolar temporary myocardial heartwire
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Oscor Bipolar Temporary Myocardial Heartwire
  • Manufacturer
    Oscor Inc

Manufacturer

Oscor Inc