BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROPHILIC COATED CURE CATHETER WITH INSERTION KIT

    MDR report key: 9339271 · Received November 18, 2019

    Report

    Report Number
    3005471919-2019-00079
    Event Type
    Injury
    Date Received
    November 18, 2019
    Date of Event
    October 21, 2019
    Report Date
    November 18, 2019
    Manufacturer
    CURE MEDICAL LLC
    Product Code
    OHR
    UDI-DI
    00815947020505
    PMA / PMN Number
    ENFORCEMENT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    INTERMITTENT CATHETER PATIENT (USER) REPORTED HE EXPERIENCED A URINARY TRACT INFECTION (UTI) AND THE CATHETER FELT DIFFERENT AFTER USING THE CATHETER PACKAGED WITH THE CATHETER INSERTION KIT (GLOVES, BZK WIPE, COLLECTION BAG, UNDERPAD).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1130289 HYDROPHILIC COATED CURE CATHETER WITH INSERTION KIT CATHETER CARE TRAY OHR CURE MEDICAL LLC HM14UK 18300102 00815947020505

    Patients

    Seq Age Sex Outcome Treatment
    1 Other