Events

Alerta De Seguridad para Trade name: SLEEVE FOR NON-SURGICAL LISA PROCESSING NON-STERILE AMBIDESTRA WITH QUALITEXX POWDER KOSSAN // Registration number: 80660070003 /// Product code: 2501490 /// Lots: 1055102; 1055103; 1055104; 2055102; 2055103; 2055104; 2065202; 2065203; 2065204; 3065102; 3065103; 3065104; 1075202; 1075203; 1075204; 1075203; 1075204; 2075202; 2075202; 2075203; 20752204; 3075202; 3075203; 3075204; 4075202; 4075203; 4075204; 1085202; 1085203; 1085204; 2085202; 2085203; 2085204; 3085202; 3085203; 3085204 / / / Product hazard class: II - medium risk.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por SUPERMED COMERCIO E IMPORTACAO DE PRODUTOS MEDICOS E HOSPITALARES LTDA; WEAR SAFE (MALASYA) SDN BHD – KOSSAN..

¿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
    1937
  • Fecha
    2016-04-01
  • 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
    The item elongation of rupture, which is responsible for the failure in the half-yearly maintenance tests of the Qualitexx glove, performed by a quality institute accredited by Inmetro, does not represent a risk of use or exposure that could cause adverse health consequences, since the risk of rupture may be evidenced at the time the wearer is wearing the glove.
  • Causa
    Disapproval of the p, m and g sizes in the semiannual trade maintenance tests, as evidenced by the certification reports of ela / l-271.626 / 16 and ela / l-273.136 / 1/16 of the certifying entity / inmetro.
  • Acción
    The company will collect the lots according to the customer's letter, in annex, for further destruction of the product./// action code: 20.

Device

Trade name: SLEEVE FOR NON-SURGICAL LISA PROCESSING NON-STERILE AMBIDESTRA WITH QUALITEXX POWDER ...

Manufacturer

SUPERMED COMERCIO E IMPORTACAO DE PRODUTOS MEDICOS E HOSPITALARES LTDA; WEAR SAFE (MALASYA) SDN B...
  • Source
    ANVSANVISA