Events

Alerte De Sécurité sur Junctional Tourniquet

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

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
    2014-10-09
  • Date de publication de l'événement
    2014-10-09
  • 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_20141009.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: sam medical products junctional tourniquet the united states food and drug administration (fda) posted a medical device safety alert concerning the accessory (axilla) strap for the sam junctional tourniquet (sjt), manufactured by sam medical products. according to the fda, the manufacturer notified affected users of a voluntary recall to address a potential issue with a clip used to secure the accessory strap used for the axilla application of the sjt. if this piece were to fail in actual use the operator may face a potential delay in using the sjt in the axilla area. all other indications of the sjt (inguinal hemorrhage and pelvic fracture) are not impacted by this issue. the manufacturer is replacing the current axilla straps with an updated version. the manufacturer has not received any reports of patient injuries to date related to this issue nor has it been reported to fail during actual patient use. for details, please refer to the following fda websites: http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm417985.Htm http://www.Fda.Gov/safety/recalls/ucm417940.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 09 october 2014.

Device

Junctional Tourniquet
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: SAM Medical Products Junctional Tourniquet
  • Manufacturer
    SAM Medical Products

Manufacturer

SAM Medical Products