Events

Alerta De Seguridad para spine supports and lower limb orthosis

Según National Institute of Drugs and Food Surveillance (INVIMA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Colombia que fue producido por Össur Inc || Ossur HF.

¿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
    I1603-131
  • Número del evento
    2014DM-0011389 ; 2014DM-0011021
  • Fecha
    2016-03-31
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=149
  • Notas / Alertas
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 recall data from the U.S. and Colombia.
  • Notas adicionales en la data
  • Causa
    The manufacturer reports that it has detected that the referenced products contain components with natural rubber latex not declared in the product, leading to the potential occurrence of adverse events in latex patients.

Device

spine supports and lower limb orthosis
  • Modelo / Serial
    COLLAR MIAMI J; UNDERSLEEVE, REBOUND and UNLODER, specific product numbers || respectively.
  • Descripción del producto
    Advanced stabilization devices for the spine and cervical area. Designed to meet the specific requirements of the patient and the doctor .---- In the immobilization in trauma, general post-surgery, dislocations, to immobilize the lower limb, pre or post-surgical immobilization of lesions of the soft tissues, use in trauma and rehabilitation, postoperative stabilization of the ankle, stable fractures, detobillo sprain of grade 2 and 3. In collateral stabilization of the articulation in moderate instabilities, helps in moderate injuries of the lateral ligaments, demenis lesions, preventing hyperexpression, in instability of the medial and lateral ligaments , in minor or moderate joint stability, articulatory protection against the remissions of sprains when resuming sports activity. In the postoperative period in which some immobilization and gradual increase in movement, tendon injuries, fractures or dislocations of the tibiotarsal joint are required, conservative management of the Metatarsus and tarsus, functional therapy of Achilles tendon rupture, chronic ligament instabilities.
  • Manufacturer
    Össur Inc || Ossur HF

Manufacturer

Össur Inc || Ossur HF
  • Empresa matriz del fabricante (2017)
    Össur hf
  • Source
    NIDFSINVIMA