Events

Alerta De Seguridad para #Product: Shadowteck Lumbar Intervertebral Spacer. #Register # 80371250007.. #Models: PSHWPB001 - 7mm; PSHWPB002 - 8mm; PSHWPB003 - 9mm; PSHWPB004 - 10mm; and PSHWPB005 - 11mm. . # Model PSHWPB001 - Shadowteck Lumbar Intervertebral Spacer - 7mm Lots: PSHW121; PSHW181; PSHW203. # Model PSHWPB002 - Shadowteck Lumbar Intervertebral Spacer - 8mm. Lots: PSHW116; PSHW182; PSHW202. # Model PSHWPB003 - Shadowteck Lumbar Intervertebral Spacer - 9mm. Lots: PSHW117; PSHW185; PSHW201. # Model PSHWPB004 - Shadowteck Lumbar Intervertebral Spacer - 10mm. Lots: PSHW118; PSHW187; PSHW200. # Model PSHWPB005 - Shadowteck Lumbar Intervertebral Spacer - 11mm. Lots: PSHW119; PSHW188; PSHW199

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Bioteck Ind.Com.Imp. e Exp. de Implantes Bio-Absorvíveis 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
    1216
  • Fecha
    2012-11-29
  • 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
    According to the company's assessment, an error has occurred and it is not a question of forgery of the product. It emphasizes that there is no risk associated with the product and / or its validity. That is, there is no risk to the health of customers / patients associated with the use of the affected product. Such an event will not cause misfortune to the clients / patients since they have received product with the expiration date informed prior to the actual expiration date of the product. ANVISA and VISA RS are following the Field Action.
  • Causa
    Detected divergence in the date of manufacture format and validity of the shadowteck lumbar spacer in relation to the format defined in the product registration process; the divergence detected is the dates printed on the labels of products in year / month / day format, and in the product registration was defined by the format day / month / year. it was found that the label dates of the shadowteck lumbar intervertebral spacer (carton) and secondary (aluminized) carton labels were in disagreement with the dates of manufacture and validity stated on the blister, which were within the expiration date less than the defined term of two years from the date of manufacture.
  • Acción
    Correction in date format on product labeling.

Device

#Product: Shadowteck Lumbar Intervertebral Spacer. #Register # 80371250007.. #Models: PSHWPB001 -...

Manufacturer

Bioteck Ind.Com.Imp. e Exp. de Implantes Bio-Absorvíveis Ltda.
  • Source
    ANVSANVISA