Events

Alerte De Sécurité sur Totalis Rigid Endo kit - BARD

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 Angiomed Gmbh & Co. Medizintechnik Kg || Productos para el Cuidado de la Salud || Cr Bard Inc || Futurematrix Interventional.

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
    I1610-426
  • Numéro de l'événement
    2015DM-0013197
  • Date
    2016-10-11
  • 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=118
  • 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 instructions for use have errors in its indication, the instructions state that the product is also indicated for use in the bile duct, however, the product is intended only to be used for the percutaneous or endoscopic treatment of urethral strictures and renal, leading to potential adverse events in patients or confusion of the care personnel.

Device

Totalis Rigid Endo kit - BARD
  • Modèle / numéro de série
    REK24N and REK26N, batches NGYIX401, NGYIX402 and NGZG1732.
  • Description du dispositif
    The BARD guides are indicated to offer transurethral or percutaneous access of the renal bladder, urethra or pelvis. BARD R INLAY / INLAYVERSAFIT suture urethral stent is indicated to alleviate obstruction in a variety of posttraumatic, malignant and benign urethral conditions, such as the presence of calculus or fragments, or other urethral obstructions such as those associated with urethral stricture, carcinoma of abdominal organs. , retroperitoneal fibrosis or urethral traumatism, or associated with extracorporeal shock wave lithotripsy (ESWL). You can place the endoprosthesis with endoscopic or percutaneous surgical techniques with a standard radiographic technique. The ECOFLEX baskets are designed to eliminate endoscopic stones, stone fragments or extraneous bodies from the kidneys, ureter or bile ducts.
  • Manufacturer
    Angiomed Gmbh & Co. Medizintechnik Kg || Productos para el Cuidado de la Salud || Cr Bard Inc || Futurematrix Interventional

Manufacturer

Angiomed Gmbh & Co. Medizintechnik Kg || Productos para el Cuidado de la Salud || Cr Bard Inc || ...
  • Source
    NIDFSINVIMA