Events

Alerta De Seguridad para Posture belt adapted to the wheelchair

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por N/A.

¿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
    804
  • Fecha
    2005-05-05
  • 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
    ANVISA through the Technovigilance Unit will be investigating if the same occurrence has been happening at the national level. If you are aware of an identical case, please contact the TechnoVigilance Unit by calling 061 - 448.1331 or 448.1485, by fax 061 - 448.1059 or by electronic means tecnovigilancia@anvisa.gov.br.
  • Causa
    "serious incidents - some of which resulted in death - were associated with the use of poorly fitted or adjusted wheelchair seat belts, which led to slipping the seat belt in the neck. all incidents have occurred with pelvic belts, this risk exists for all or other types of belts. ".
  • Acción
    "Where the belt is not adjusted by the manufacturer of the wheelchair, the belt dealer shall provide the appropriate information, including data on the compatibility of the belt with the wheelchair, as well as instructions for adjustment, adjustment and maintenance in such a way as to The adjustment of the belt should be checked regularly to ensure that this posture is maintained. Inspection and maintenance of the seat belts, as well as of their adaptations to the seat, should be included in the preventive maintenance program of the seat. "The research has shown that these incidents can occur with belt deviations from the correct position of only 15 cm. The risk is higher for individuals who have some degree of mental deficiency, reduced motor coordination or myasthenia of the upper limbs."

Device

Posture belt adapted to the wheelchair
  • Modelo / Serial
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA