Events

Alerte De Sécurité sur Doyen-Collin Mouth Gag 120mm

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

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
    2018-02-14
  • Date de publication de l'événement
    2018-02-14
  • 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_20180214a.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: aesculap ag doyen-collin mouth gag 120mm medical device manufacturer, aesculap ag, has issued a medical device safety alert concerning its doyen-collin mouth gag 120mm [om040r; production period from february 2016 to october 2017]. an affected product om040r can be clearly identified by two options: identification on the basis of the labelled production date (from 02 16 to 10 17 inclusively), identification on the basis of the labelled encoding (from 000330 to 000449 inclusively). the manufacturer received knowledge about the possibility that the plastic sleeves of a doyen-collin mouth gag 120mm - om040r could stick together after reprocessing. according to the manufacturer, the used plastic sleeves of the instrument do not meet the valid specification. instead of the specified material silicone, the material pvc was used for the manufacturing of the sleeves. this could render affected instruments unusable after reprocessing. the results of investigation revealed that there is no increased risk expected for patients who have been treated with the affected product. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 14 february 2018.

Device

Doyen-Collin Mouth Gag 120mm
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Aesculap AG Doyen-Collin Mouth Gag 120mm
  • Manufacturer
    Aesculap AG

Manufacturer

Aesculap AG