Events

Alerte De Sécurité sur TISSUE-GUARD Family of Products - VASCU-GUARD, DURA-GUARD, PERI-GUARD and SUPPLE PERI-GUARD

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Baxter.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2013-10-16
  • Date de publication de l'événement
    2013-10-16
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131016d.html
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    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
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Baxter TISSUE-GUARD Family of Products - VASCU-GUARD, DURA-GUARD, PERI-GUARD and SUPPLE PERI-GUARD
  • Manufacturer
    Baxter

Manufacturer

Baxter