Events

Alerta De Seguridad para Trade Name: Glove for Non-Surgical Supermax Procedure. ANVISA Registration 80105840002. Hazard Class I. Affected Model: Supermax Premium Quality manufactured by Supermax Glove Manufacturing SDN BHD. Lots 70118/71726 / 71725. Affected sizes: PP, P and G.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Supermax Brasil Importadora S/A.; Supermax Glove Manufacturing SDN BHD..

¿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
    1875
  • Fecha
    2016-04-14
  • 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
    Recommendations to users and patients: If you have products from the affected lots in your inventory, segregate them in a way that is not used, and contact the company's SAC through 0800-600-8880 or sac@supermax-brasil.com for arrangements exchange.
  • Causa
    Gloves for non-surgical procedure with powder were disregarded in a conformity maintenance test performed by the product certificate body. the result of the microbiological test was above the parameters established by ordinance 332/2012 of inmetro, presenting a bacteria colony forming unit limit above that allowed. supermax brasil importadora s / a is evaluating with the manufacturer the causes of this occurrence, to verify the scope of the problem, which may be related to manufacturing faults or failures in the storage process in the distribution chain.
  • Acción
    Action code 01/2016. Gathering.

Device

Trade Name: Glove for Non-Surgical Supermax Procedure. ANVISA Registration 80105840002. Hazard Cl...

Manufacturer

Supermax Brasil Importadora S/A.; Supermax Glove Manufacturing SDN BHD.
  • Source
    ANVSANVISA