Events

Safety Alert for DENTAL FILM, TAPE CONTAINER WITH LEAD PROTECTION COATING

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

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
    35
  • Date
    2001-04-14
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Reason
    Fda food and drug administration issued a notice of public health alerting potential health professionals risk of harmful exposure to lead due to failure of painting or coating isolating the lead nestes recipi.
  • Action
    The FDA RECOMMENDS: (1) DISCARD ANY FILM THAT HAS BEEN PLACED IN THESE CONTAINERS. NONE OF THESE MOVIES MUST BE USED. SCRATCHING THE MOVIE DOES NOT REDUCE LEVEL LEVELS. (2) REMOVE THE USE OF THESE CONTAINERS AND DISPOSE OF PROPERLY, ALL LEAD TRASHING MUST BE DISPOSED OF IN ACCORDANCE WITH THE ENVIRONMENTAL PROTECTION LAW. (3) SAVE YOUR DENTAL FILMS ACCORDING TO THE MANUFACTURER'S INSTRUCTIONS. ANVISA HAS AN INTEREST TO KNOW ABOUT COMPLAINTS OF CONSEQUENCES OBSERVED WITH PATIENTS AND HEALTH PROFESSIONALS RELATED TO THIS EXHIBITION.

Device

DENTAL FILM, TAPE CONTAINER WITH LEAD PROTECTION COATING
  • Model / Serial
  • Manufacturer
    NENHUMA

Manufacturer

NENHUMA
  • Source
    ANVSANVISA