Events

Alerte De Sécurité sur Trade name: Valvulotomo Hydro Lemaitre Longo. Technical Name: Valvulotomo. ANVISA registration number: 80202919003. Class of risk: II. Affected Model:. Serial numbers affected: ELVH1082V

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
    1985
  • Date
    2016-09-14
  • 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
    Recommendations to users and patients: The manufacturer requested the collection of the lot and the proper segregation of the units collected. After the recall, the manufacturer requests that all units be sent to Lemaitre. Regarding the products that were already used, the manufacturer did not request any further action.
  • Cause
    The company clarifies that on 05/08/2016, an official recall statement was received from the manufacturer lemaitre vascular inc, of the product valvulootro hydro longo lemaitre, model 1009-00, lot elvh1082v, of which 5 units were sent to brazil and received on 06/23/2016, according to nf 60436. such collection is due to reported failure to close hoops at the moment of the drive. in some cases, this problem was discovered during use. although there are no reports of adverse events, there is a possibility that a malfunction of the device could damage the vessel at the time of withdrawal. the manufacturer requested the collection of the lot and the proper segregation of the collected units. after the recall, the manufacturer requests that all units be sent to lemaitre. regarding the products that were already used, the manufacturer did not request any further action.
  • Action
    Field Action No. CWB21 triggered under the responsibility of Tecmedic Comércio de Produtos Médicos Ltda. Risk classification: III (Risk of serious adverse event occurrence) Classification of the field action: Recollection; Return to the manufacturer.

Device

Trade name: Valvulotomo Hydro Lemaitre Longo. Technical Name: Valvulotomo. ANVISA registration nu...

Manufacturer

TECMEDIC COMÉRCIO DE PRODUTOS MÉDICOS LTDA.; Lemaitre Vascular Inc.
  • Source
    ANVSANVISA