Events

Alerta De Seguridad para - Trade name: NUGARD TRIMMER DISCHARGE PROCEDURE ** Registration number: 80273450001 ** Risk class: I - LOW RISK ** Technical name: Disposable gloves ** Display: G; M; P; PP -. UPDATED 1/15/2014 - batches 20118; 20277; 20624; 20798; 21071; 21188; 20119; 20120; 20278; 20279; 20636; 20799; 20898; 20899; 21063; 21064; 21065; 21066; 21072; 21073; 21074; 21189; 21190; 20121; 20122; 20280; 20281; 20625; 20626; 20802; 20900; 20901; 21067; 21068; 21069; 21070; 21075; 21076; 21077; 21191; 21192; 20123; 20282; 20627 and 20803.

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

¿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
    1343
  • Fecha
    2013-12-17
  • 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
    Any questions about this field action, please contact the company, through the email responsaveltecnica@olimed.com.br and telephones (47) 3144-97010 and 0800-645-2480.
  • Causa
    Suspension of authorization for the use of the conformity identification seal by the product certification body (ocp) motivated by the failure in the semi-annual maintenance tests, according to reports ela / l-239.217 / 13; ela / l-239.217 / 1/13; ela / l-239.878 / 13, issued by ocp.
  • Acción
    Company should trigger Field Action. UPDATED ON 01/15/2014 - The company is collecting lots for the period .//// UPDATED on 12/15/2014 - The IFBQ forwarded document Ref 1808/2014 notifying that the suspension of the authorization to use the seal , considering that the company carried out the corrective actions and was approved in the tests provided for in the Conformity Assessment Regulation.

Device

- Trade name: NUGARD TRIMMER DISCHARGE PROCEDURE ** Registration number: 80273450001 ** Risk clas...

Manufacturer

OLIMED MATERIAL HOSPITALAR LTDA