Events

Alerta De Seguridad para DENTAL FILM, TAPE CONTAINER WITH LEAD PROTECTION COATING

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por NENHUMA.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    35
  • Fecha
    2001-04-14
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Causa
    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.
  • Acción
    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
  • Modelo / Serial
  • Manufacturer
    NENHUMA

Manufacturer

NENHUMA
  • Source
    ANVSANVISA