Events

Alerta De Seguridad para Handle, flexible

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por DePuy 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
    2013-04-16
  • Fecha de publicación del evento
    2013-04-16
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130416.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 handle, flexible medical device manufacturer, depuy synthes, has issued a field safety notice concerning the “handle, flexible [no.: 355.220]”. all lot numbers of the old handle (355.280) are affected. the manufacturer is initiating a voluntary recall of all lots of the "handle, flexible, for no. 355.220" (355.280) which is part of the simplified universal nail system (sun) and the universal nail system (uni), due to the potential lack of the ability to thoroughly clean the instrument. it was reported by the evaluation department in monument/usa that while checking the instrument set a discharge from the handle, flexible was noted. additionally, an investigation was unable to validate the ability to adequately clean the instrument. there have been no complaints or adverse events with regards to the issue. the manufacturer advises users to remove the affected product from use and return them to synthes. the handles in the field will be replaced with a newly design handle. according to the local supplier, the affected devices were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 16 april 2013.

Device

Handle, flexible
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Synthes Handle, flexible
  • Manufacturer
    DePuy Synthes

Manufacturer

DePuy Synthes