Events

Alerte De Sécurité sur Wound Management Ltd. TOPPER Xtra Absorbent Dressing Pads

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

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
    2014-07-17
  • Date de publication de l'événement
    2014-07-17
  • 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_20140717b.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: systagenix wound management ltd. topper xtra absorbent dressing pads medical device manufacturer, systagenix wound management ltd., has issued a field safety notice (fsn) concerning topper xtra absorbent dressing pads (product code: m11121n, m11131, m11141, p55263, p55264 and p55255). the manufacturer has become aware that the sterility of some product may be compromised due to small holes in the bottom layer of the primary pouch; its subsequent use may therefore pose a potential risk of localised infection. the manufacturer advises users to immediately segregate and discontinue use of the affected products. clinicians should immediately discontinue use of the affected products, and monitor any patients who were using, or have recently used, any of the affected product for signs of localised infection, including heat, pain, redness or swelling around the wound or increased wound drainage. 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 17 jul 2014.

Device

Wound Management Ltd. TOPPER Xtra Absorbent Dressing Pads
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Systagenix Wound Management Ltd. TOPPER Xtra Absorbent Dressing Pads
  • Manufacturer
    Systagenix Wound Management Ltd.

Manufacturer

Systagenix Wound Management Ltd.