BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWIST CATHETER

    MDR report key: 7000646 · Received November 3, 2017

    Report

    Report Number
    3005471919-2017-00005
    Event Type
    Injury
    Date Received
    November 3, 2017
    Date of Event
    October 4, 2017
    Report Date
    November 3, 2017
    Manufacturer
    CURE MEDICAL LLC
    Product Code
    KOD
    UDI-DI
    00815947020380
    PMA / PMN Number
    K080881
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    USER EXPERIENCED AN URINARY TRACT INFECTION DURING ROUTINE INTERMITTENT CATHETERIZATION. USER HAS A HISTORY OF REPEATED URINARY TRACT INFECTIONS AND AS A RESULT HER DOCTOR HAS SUSPENDED CATHETERIZATION FOR 2 MONTHS AND HAS PRESCRIBED AN ANITIBIOTIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779650 TWIST CATHETER URINARY CATHETER KOD CURE MEDICAL LLC T12 170419-1 00815947020380

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other