Events

Alerta De Seguridad para TISSUE-GUARD Family of Products - VASCU-GUARD, DURA-GUARD, PERI-GUARD and SUPPLE 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
    2013-10-16
  • Fecha de publicación del evento
    2013-10-16
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131016d.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 tissue-guard family of products - vascu-guard, dura-guard, peri-guard and supple peri-guard medical device manufacturer, baxter, has issued a field safety notice concerning tissue-guard family of products - vascu-guard, dura-guard, peri-guard and supple peri-guard. the affected products can be identified as follows: product code: pc-0608nsp product description: peri-guard, 6x8 cm the affected lot serial numbers: spce113-04d0044, spce113-04d0102, spce113-07g0048, spce113-feb0079 and spce113-jan0118 it has been determined that specific shipping configurations in which more than eight 6 ounce units are shipped together with a specific revision of the instructions for use can place pressure on the package, which can lead to damage and leakage. there are no reports of patient involvement or any known adverse events associated with this issue. improvements to the packing and shipping processes have been implemented to help eliminate this issue. the manufacturer advises users to discontinue use of the affected products and return them to baxter for replacement. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the product, please contact your supplier for necessary actions. posted on 16 october 2013.

Device

TISSUE-GUARD Family of Products - VASCU-GUARD, DURA-GUARD, PERI-GUARD and SUPPLE PERI-GUARD
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Baxter TISSUE-GUARD Family of Products - VASCU-GUARD, DURA-GUARD, PERI-GUARD and SUPPLE PERI-GUARD
  • Manufacturer
    Baxter

Manufacturer

Baxter