Events

Alerte De Sécurité sur Trade Name: ENXERTO PERFECTHA DERM DEEP. Active Principle: Hyaluronic Acid. N. Anvisa Reg.: 80230190003

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 Comédix Comércio de Produtos Médicos e Farmacêuticos Ltda; Hangzhou Gallop Biological Products Co. LTD.

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
    824
  • Date
    2006-02-15
  • 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
    Anvisa will continue to follow the case, in order to ensure that health products marketed in Brazil have the safety and efficacy necessary for the good performance of the product.
  • Cause
    Comédix comércio de produtos médicos e farmacêuticos ltda is initiating recall of perfectra derm graft product due to printing errors detected on the label material of the packages and their respective package inserts. the company informs that such inaccuracies do not imply any influence on the composition, quality or efficacy of the products, nor do they lead to compromise of its application or administration. lots / date of fab / val date / imported quantity: lot 050823 / fab. 08-2005 / val. 08-2007 / 812 units; lot 050426 / fab. 04-2005 / val 04-2007 / 28 units. presentation: 1.0 ml quantity sold in brazil: lot 050823 - 812 units lot 050426 - 09 units.
  • Action
    The company Comédix: - notified the incident to Anvisa; - Sent an advertising message, published in the Jornal do Comércio Brasil, on 01/03/2006, with a communiqué informing the event and calling on those who have intact units of the product to contact the SAC on 0800 999 139, so that it is feasible and replaced. UPDATE OF INFORMATION (05/31/2006) - THE COMPANY REPORTED THAT THERE WAS NO RETURN OF ANY UNIT OF THE COMMERCIALIZED PRODUCT, WHICH IS IN QUESTION. SO, AFTER ABOUT 03 MONTHS OF THE ANNOUNCEMENT, THE COMPANY REPORTS THAT IT IS GIVING THE CASE CLOSED. THE COMPANY ALREADY CORRECTED THE PRINT ERROR.

Device

Trade Name: ENXERTO PERFECTHA DERM DEEP. Active Principle: Hyaluronic Acid. N. Anvisa Reg.: 80230...

Manufacturer

Comédix Comércio de Produtos Médicos e Farmacêuticos Ltda; Hangzhou Gallop Biological Products Co...
  • Source
    ANVSANVISA