Events

Alerte De Sécurité sur PHYSIOMESH Flexible Composite Mesh

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

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
    2016-05-31
  • Date de publication de l'événement
    2016-05-31
  • 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_20160531c.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: ethicon physiomesh flexible composite mesh medical device manufacturer, ethicon, has issued a medical device safety alert concerning its physiomesh flexible composite mesh [all product codes]. the manufacturer has initiated a worldwide medical device removal of ethicon physiomesh flexible composite mesh (for laparoscopic use). the manufacturer is removing the product following an analysis conducted at the request of the ethicon medical safety team of unpublished data from two large independent hernia registries (herniamed german registry and danish hernia database-dhdb). the recurrence/ reoperation rates (respectively) after laparoscopic ventral hernia repair using ethicon physiomesh flexible composite mesh were higher than the average rates of the comparator set of meshes among patients in these registries. based on the currently available data, the manufacturer believes that the higher rates to be a multifactorial issue (including possible product characteristics, operative and patient factors), but the manufacturer have not been able to fully characterize these factors. consequently, the manufacturer has not been able at this time to issue further instructions to surgeons that might lead to a reduction in the recurrence rate and have decided to remove ethicon physiomesh composite mesh from the global market. health care practitioners that have treated patients using ethicon physiomesh composite mesh are advised to follow those patients in the usual manner. 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 31 may 2016.

Device

PHYSIOMESH Flexible Composite Mesh
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Ethicon PHYSIOMESH Flexible Composite Mesh
  • Manufacturer
    Ethicon

Manufacturer

Ethicon