Events

Alerte De Sécurité sur spine supports and lower limb orthosis

Selon National Institute of Drugs and Food Surveillance (INVIMA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Colombia qui a été fabriqué par Össur Inc || Ossur HF.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    I1603-131
  • Numéro de l'événement
    2014DM-0011389 ; 2014DM-0011021
  • Date
    2016-03-31
  • Pays de l'événement
    Colombia
  • Source de l'événement
    INVIMA
  • URL de la source de l'événement
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=149
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
    COLLAR MIAMI J; UNDERSLEEVE, REBOUND and UNLODER, specific product numbers || respectively.
  • Description du dispositif
    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
  • Société-mère du fabricant (2017)
    Össur hf
  • Source
    NIDFSINVIMA