Events

Alerte De Sécurité sur ALL PRODUCTS OF THE COMPANY SANTE TEXTIL LTDA.

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 SANTE TEXTIL 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
    1203
  • Date
    2012-11-21
  • 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 takes this measure considering that, in Investigative Inspection on 09/12, the company was not located at the declared address. In addition, the Sanitary Vigilance of Joinvile reported that the company had requested the shutdown of its manufacturing activities in 05/2012. Invoices were evidenced after this date. In Investigative Inspection was spotted production in place without Operation Permit. Anvisa / Utvig follows this case.
  • Cause
    Suspension determination of manufacturing, distribution, trade and use. seizure and destruction of existing stock in the market, according to resolution - re n °. 4,843, dated november 12, 2012. dou n ° 219 of 11/13/2012 attached. http://portal.Anvisa.Gov.Br/wps/wcm/connect/41c92d804d87ef40a4e5e5c116238c3b/re4.843.Pdf?mod=ajperes.
  • Action
    Check the product for stock and segregate. Do not use the product. Contact your local Sanitary Surveillance to monitor product destruction. Contact supplier to negotiate refund.

Device

ALL PRODUCTS OF THE COMPANY SANTE TEXTIL LTDA.

Manufacturer

SANTE TEXTIL LTDA
  • Source
    ANVSANVISA