Events

Alerta De Seguridad para Guide Wire Ø 2.5 mm, with drill tip, length 300 mm, Cobalt-Chrome Alloy

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

¿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
    2013-05-08
  • Fecha de publicación del evento
    2013-05-08
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130508e.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: synthes guide wire ø 2.5 mm, with drill tip, length 300 mm, cobalt-chrome alloy medical device manufacturer, synthes, has issued a field safety notice concerning guide wire ø 2.5 mm, with drill tip, length 300 mm, cobalt-chrome alloy with part number 338.002. according to synthes, wrong material (stainless steel) is indicated on the product label. the product is made of cobalt chrome (l605). the mislabelled product, if detected, may result in user dissatisfaction and use of an alternative product with no harm anticipated. there is an unlikely potential that a user may desire to use a stainless steel guide wire because the patient has a known sensitivity to cobalt chrome-alloy. although highly unlikely, if this situation were to occur the patient could experience an adverse tissue reaction. according to the local supplier, the affected devices were not distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 08 may 2013.

Device

Guide Wire Ø 2.5 mm, with drill tip, length 300 mm, Cobalt-Chrome Alloy
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Synthes Guide Wire Ø 2.5 mm, with drill tip, length 300 mm, Cobalt-Chrome Alloy
  • Manufacturer
    Synthes

Manufacturer

Synthes