Events

Alerte De Sécurité sur Name: Desensibilize Nano-P - Número do Registro: 80172310042 - Technical Name: Subst.P / Treatment Hypersensitivity Dentinaria - Risk Class: II - MEDIUM-RISK - Affected lots: 100415; 040215 (Distribution map in ANNEX)

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 Dentscare 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
    1688
  • Date
    2014-09-16
  • 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
    The company recommends "... It is recommended not to use products from batches 040215 and 100415, because the product may cause irritation to the soft tissues of the mouth. In case of suspected adverse effects mentioned in individuals subject to the use of the product, recommends clinical monitoring until remission of signs and symptoms. "
  • Cause
    Products in batches 040215 and 100415 show changes in ph content which may lead to irritation of the oral soft tissues. according to the company, to evaluate the risks involved were investigated in isolation the raw materials used in the product, but no changes were identified in the standards. we also investigated the production processes where they found that products from the milling process of hydroxyapatite had ph values ​​above the usual.
  • Action
    Company is promoting the collection of lots under risk in Brazil, according to the Letter to Customers (APPENDIX). Code VPV001

Device

Name: Desensibilize Nano-P - Número do Registro: 80172310042 - Technical Name: Subst.P / Treatmen...

Manufacturer

Dentscare Ltda