Events

Alerte De Sécurité sur Trade name: Valvulotome Hydro Longo Lemaitre ANVISA Registration Number: 80202919003 Hazard Class: II Affected Model: 1009-00 Serial Numbers Affected: ELVH1102V

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Tecmedic Comércio de Produtos Médicos Ltda; Lemaitre Vascular Inc.

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
  • ID de l'événement
    2187
  • Date
    2017-02-07
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Notes supplémentaires dans les données
    For products that were already used in patient, the manufacturer did not request any further action.
  • Cause
    Tecmedic comércio de produtos médicos ltda., on 05/02/2017 received notification of collection of lot elvh1102v of reference 1009-00 of the product valvulotomo hydro longo lemaitre, registered with anvisa under nº 80202919003. this collection was initiated due to to reported problems of failure of the rims to close when the device was triggered. in some cases, this problem was discovered in use and led to damage in the vessel. if the blades are locked in the open position, the device must be removed in the open position. removal of the unassembled device may cause damage to the vein or during use or when the blades pass through the vessel. the manufacturer lemaitre requested the immediate recall of the valvulotomo hydro long lemaitre, model 1009-00, lot elvh1102v and the proper segregation of the parts. after this recall, the manufacturer requested that all units be shipped to lemaitre. for the valvuloto hydro long lemaitre units of the elvh1102v batch used, the manufacturer did not request any further action. tecmedic imported 23 units from the affected lot.
  • Action
    Field Action Code CWB 02/2017 triggered under the responsibility of the company Tecmedic Comércio de Produtos Médicos Ltda. Company will collect.

Device

Trade name: Valvulotome Hydro Longo Lemaitre ANVISA Registration Number: 80202919003 Hazard Class...

Manufacturer

Tecmedic Comércio de Produtos Médicos Ltda; Lemaitre Vascular Inc
  • Source
    ANVSANVISA