BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURE MALE ULTRA

    MDR report key: 10094336 · Received May 27, 2020

    Report

    Report Number
    3005471919-2020-00043
    Event Type
    Injury
    Date Received
    May 27, 2020
    Date of Event
    April 27, 2020
    Report Date
    May 27, 2020
    Manufacturer
    INTEGRAL MEDICAL PRODUCTS CO., LTD.
    Product Code
    KOD
    PMA / PMN Number
    K080881
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS TO FOLLOW UP WITH THE PATIENT (USER) AND GAIN ADDITIONAL INFORMATION DID NOT RECEIVE A RESPONSE. LIMITED INFORMATION ABOUT THE EVENT WAS AVAILABLE. PATIENT WAS USING FOUR DIFFERENT DEVICES SO WE CANNOT DETERMINE IF ANY ONE OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE OTHER SUSPECT DEVICES HAVE BEEN REPORTED ON SEPARATE MEDICAL DEVICE REPORTS.

    Description of Event or Problem · 1

    INTERMITTENT CATHETER PATIENT (USER) SAID THE SAMPLES (AS WELL AS OTHERS SENT) DID NOT WORK AND HE GOT A URINARY TRACT INFECTION (UTI) FROM USING THE M16C CATHETER WITH THE K2 CATHETER INSERTION KIT (GLOVES, BZK WIPE, COLLECTION BAG, UNDERPAD) AND ULTRA M16C WITH THE K1 CATHETER INSERTION KIT (GLOVES, BZK WIPE, COLLECTION BAG, UNDERPAD).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556946 CURE MALE ULTRA URINARY CATHETER KOD INTEGRAL MEDICAL PRODUCTS CO., LTD. ULTRA M16C

    Patients

    Seq Age Sex Outcome Treatment
    1 Other