Events

Alerte De Sécurité sur HEAD INTERCHANGEABLE INCOMEPE (Anvisa Registry 10395270017) - LOT: 023906

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 INCOMEPE INDÚSTRIA DE MATERIAIS CIRÚRGICOS LTDA - CNPJ: 57.212.870/0001-41..

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
    1088
  • Date
    2011-08-24
  • 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
    Additional information must be obtained from INCOMEPE INDÚSTRIA DE MATERIAIS CIRÚRGICOS LTDA, through Tel .: (011) 4615-4666 or e-mail lborri@incomepe.com.br. #### THIS ALERT MAY BE MODIFIED AT ANY TIME TO UPDATE INFORMATION, SO ALWAYS CONFIRM IF YOU HAVE IN HAND THE MOST RECENT VERSION #### ON 14-09-2011 UPDATED ITEM 3 OF ACTION DESCRIPTION ### # Alert ended 2/2/2013. SEE ALERTS OF TECNOVIGILANCE N ° 1213 E 1231.
  • Cause
    Unsatisfactory results in the product, according to the test report (protocol 178/10) issued by lamef / ufrgs and problems in the manufacturing process, evidenced during the fiscal inspection carried out in the company, which subsidized the publication of re 3.621 / 2011 in dou n ° 159, of august 18, 2011.
  • Action
    Healthcare establishments and / or distributors that own lots of affected products must: (1) Suspend the commercialization and implant the affected lot; (2) segregate and identify affected products so that they are not inadvertently used; (3) Contact the product registration holder for further information as well as other measures to be taken.

Device

HEAD INTERCHANGEABLE INCOMEPE (Anvisa Registry 10395270017) - LOT: 023906

Manufacturer

INCOMEPE INDÚSTRIA DE MATERIAIS CIRÚRGICOS LTDA - CNPJ: 57.212.870/0001-41.
  • Source
    ANVSANVISA