Events

Alerta De Seguridad para Dura-Guard and Peri-Guard

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

¿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
    2014-07-31
  • Fecha de publicación del evento
    2014-07-31
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140731.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: baxter dura-guard and peri-guard medical device manufacturer, baxter, has issued a field safety notice (fsn) concerning dura-guard (product codes: dg0209snbio, dg0404snbio, dg0608snbio, dg0814snbio) and peri-guard (product code: pc0608n). the manufacturer reminds customers of the approved indications for use for dura-guard and peri-guard. this notification is being sent due to two recent reports involving use of the incorrect product during surgery. dura-guard has the approved indication for use as a dura substitute for the closure of dura mater during neurosurgery. peri-guard is intended for repair of pericardial structures and for use as prosthesis for the surgical repair of soft tissue deficiencies, and it is also intended for use as a patch material for intra-cardiac defects, great vessel, septal defect and annulus repair, and suture-line buttressing. the manufacturer advises users that only dura-guard is indicated for use as a dura substitute. peri-guard should not be used as it is not indicated for this type of use. users can continue to use the concerned products according to their instructions for use. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 31 july 2014.

Device

Dura-Guard and Peri-Guard
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Baxter Dura-Guard and Peri-Guard
  • Manufacturer
    Baxter

Manufacturer

Baxter