Events

Safety Alert for 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)

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Dentscare Ltda.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1688
  • Date
    2014-09-16
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    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. "
  • Reason
    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