BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURE MALE ULTRA

    MDR report key: 7687469 · Received July 13, 2018

    Report

    Report Number
    3005471919-2018-00020
    Event Type
    Injury
    Date Received
    July 13, 2018
    Date of Event
    June 1, 2018
    Report Date
    October 2, 2020
    Manufacturer
    CURE MEDICAL LLC
    Product Code
    KOD
    PMA / PMN Number
    K080881
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT ALSO PROVIDED ANOTHER LOT NUMBER, 170819-1, BUT WAS UNABLE TO CONFIRM THE LOT NUMBER OF THE UNIT THAT CAUSED THE UTI AND IF IT WAS FROM THIS LOT.

    Description of Event or Problem · 1

    PATIENT (USER) EXPERIENCED A URINARY TRACT INFECTION (UTI) AFTER USING ULTRA M14 CATHETER. USER STATED THERE WAS NO PROBLEM WITH THE PRODUCT AND HE DID NOT EXPERIENCE ANY INJURIES. IT WAS JUST NOT A HYDROPHILIC PRODUCT WHICH HE REQUIRES BECAUSE IT IS MORE SLIPPERY AND CAUSES LESS FRICTION TO HIS URETHRA. HE HAS BEEN USING A HYDROPHILIC CATHETER FOR A LONG TIME AND HIS SUPPLIER SENT HIM ULTRA M14 TO TRY WITHOUT EXPLAINING IT IS NOT A HYDROPHILIC PRODUCT. HE WAS PRESCRIBED AN ANTIBIOTIC AND HAS FULLY RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527177 CURE MALE ULTRA URINARY CATHETER KOD CURE MEDICAL LLC ULTRA M14 170828-5

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other