Events

Safety Alert for Totalis Rigid Endo kit - BARD

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Angiomed Gmbh & Co. Medizintechnik Kg || Productos para el Cuidado de la Salud || Cr Bard Inc || Futurematrix Interventional.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    I1610-426
  • Event Number
    2015DM-0013197
  • Date
    2016-10-11
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=118
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Model / Serial
    REK24N and REK26N, batches NGYIX401, NGYIX402 and NGZG1732.
  • Product Description
    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