Events

Alerte De Sécurité sur Sterile Thread for Face Correction PDO Thread (Absorbable Polydioxanone Suture): 3D COG Thread L (3D-23G-90mm), COG PDO Tread Blunt (3DB19G-100mm), 3D COG Thread Sharp (3D-22G70mm)

Selon Ministry of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Lithuania qui a été fabriqué par Not specified.

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
  • Numéro de l'événement
    6
  • Date
    2017-11-24
  • Pays de l'événement
    Lithuania
  • Source de l'événement
    MH
  • URL de la source de l'événement
    http://www.vaspvt.gov.lt/node/115
  • Notes / Alertes
    Data from Lithuania is current through December 2018. All of the data comes from the Ministry of Health, 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 recall data from the U.S. and Lithuania.
  • Notes supplémentaires dans les données
  • Cause
    The medical devices are marked with two ce conformity marks with the number of the notified bodies 1282 and 0197. in accordance with the provisions of the regulation, the ce marking must be accompanied by the identification number of one of the notified bodies responsible for applying the procedures set out in the annexes to this regulation. in addition, the ce mark does not conform to the form set out in annex 12 to the regulation. such marking does not comply with the requirements of articles 38-40 of the regulation; instructions for use have not been added to medical devices as required by annex 1, paragraph 14.1 of the regulation; medical devices do not include the name and address of the manufacturer and the authorized representative within the european union and its address as required by annex 1, paragraph 14.3.1 of the regulation.
  • Action
    Not allowed to enter the Lithuanian market

Device

Sterile Thread for Face Correction PDO Thread (Absorbable Polydioxanone Suture): 3D COG Thread L ...

Manufacturer

Not specified
  • Représentant du fabricant
    UAB Urmo Group
  • Source
    MH