Alerta De Seguridad para ACETÁBULO DE MULLER INCOMEPE (Registro Anvisa 10395270012) - LOTE: 018089

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por INCOMEPE INDÚSTRIA DE MATERIAIS CIRÚRGICOS LTDA - CNPJ: 57.212.870/0001-41..

¿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
    1089
  • Fecha
    2011-08-24
  • País del evento
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
  • 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
    Additional information must be obtained from INCOMEPE INDÚSTRIA DE MATERIAIS CIRÚRGICOS LTDA, through Tel .: (011) 4615-4666 or e-mail lborri@incomepe.com.br. #### THIS ALERT MAY BE MODIFIED AT ANY TIME TO UPDATE INFORMATION, SO CONFIRM EVER IF YOU HAVE IN HAND THE LATEST VERSION #### 02/09/2011 - RETIFICED PRODUCT REGISTRATION NUMBER #### # ### IN 14-09-2011 UPDATED ITEM 3 OF DESCRIPTION OF ACTION #### Alert ended 2/2/2013. SEE ALERTS OF TECNOVIGILANCE N ° 1213 E 1231.
  • Causa
    Unsatisfactory results in the product, according to the test report (protocol 178/10) issued by lamef / ufrgs and problems in the manufacturing process, evidenced during the fiscal inspection carried out in the company, which subsidized the publication of re 3.621 / 2011 in dou n ° 159, of august 18, 2011.
  • Acción
    Healthcare establishments and / or distributors that own lots of affected products must: (1) Suspend the commercialization and implant the affected lot; (2) segregate and identify affected products so that they are not inadvertently used; (3) Contact the product registration holder for further information as well as other measures to be taken.