BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URODYNAMIC URINARY CATHETER

    MDR report key: 11207568 · Received January 20, 2021

    Report

    Report Number
    MW5098931
    Event Type
    Malfunction
    Date Received
    January 20, 2021
    Date of Event
    January 12, 2021
    Report Date
    January 18, 2021
    Manufacturer
    LABORIE MEDICAL TECHNOLOGIES, CANADA ULC
    Product Code
    FEN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    URODYNAMIC CATHETER MALFUNCTIONED LEADING TO READING HIGH PRESSURES. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101802 URODYNAMIC URINARY CATHETER DEVICE, CYSTOMETRIC, HYDRAULIC FEN LABORIE MEDICAL TECHNOLOGIES, CANADA ULC CAT895 192516

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR