Events

Alerte De Sécurité sur Safil and Novosyn

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

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
    2018-06-13
  • Date de publication de l'événement
    2018-06-13
  • 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_20180613b.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: b. braun surgical, s.A safil and novosyn medical device manufacturer, b. braun surgical, s.A, has issued a medical device safety alert concerning its safil and novosyn, sterile absorbable surgical multifilament suture. from an internal non-conformity, the manufacturer detected that some units of the mentioned products have the pack damaged; as a consequence the product sterility is compromised. according to the manufacturer, wound infection (e.G. endomyometritis, localized/generalized peritonitis), abscess formation, adhesions, risk of wound dehiscence, sepsis that could lead to life-threatening injury. treatment or reoperation might be necessary. the manufacturer would not recommend any specific monitoring of the patients that have been treated with the involved products since there is a risk of infection innate in any type of surgery. the hospital should act according to their established protocol for such complications. affected users are instructed to identify and quarantine if the affected product in their warehouse. product recall is on-going. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 13 june 2018.

Device

Safil and Novosyn
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: B. Braun Surgical, S.A Safil and Novosyn
  • Manufacturer
    B

Manufacturer

B