Events

Alerte De Sécurité sur DISCHARGE EQUIPMENT DESCARPACK, Registry nº 10330669037, lot: NEMA035, Fab. 09/2012, Val. 08/2017

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 Descarpack Descartáveis do Brasil Ltda.

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
    1359
  • Date
    2014-02-17
  • 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
    UPDATE - 02/24/2014 - The company informs that the recall action has begun and that customers and patients who identify the product must contact the company's SAC by telephone (81) 3538-0730 and e- mail sac.ne@descarpack.com.br //////// UPDATE - 07/13/2014 - The company sent the field action completion form. 800 units of the product were collected and incinerated.
  • Cause
    According to the single sample tax report no. 113.245230, issued by the central laboratory of public health professor gonçalo moniz of the health department of the state of bahia, the product dischargeable equipment descarpack, lot nema035, was considered unsatisfactory in the aspect test ( presence of foreign body and the protective cover of the male connection being disconnected).
  • Action
    Resolution RE No. 493, of February 14, 2014, determined, as a sanitary measure, the suspension of distribution, trade and use, as well as the collection, throughout the national territory, of the product DISCHARGEABLE EQUIPMENT DESCARPACK, lot NEMA035

Device

DISCHARGE EQUIPMENT DESCARPACK, Registry nº 10330669037, lot: NEMA035, Fab. 09/2012, Val. 08/2017

Manufacturer

Descarpack Descartáveis do Brasil Ltda