BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURE CATHETER

    MDR report key: 10399635 · Received August 12, 2020

    Report

    Report Number
    3005471919-2020-00087
    Event Type
    Injury
    Date Received
    August 12, 2020
    Date of Event
    May 25, 2020
    Report Date
    August 12, 2020
    Manufacturer
    CURE MEDICAL LLC
    Product Code
    EZD
    UDI-DI
    008159947020048
    PMA / PMN Number
    K072539
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DURING FOLLOW-UP, THE PATIENT SAID HE DID NOT NOTICE ANY DEFECT OR MALFUNCTION WITH THE CATHETERS. THE PATIENT ALSO PROVIDED ANOTHER LOT NUMBER, 191223-1, BUT WAS UNABLE TO CONFIRM THE LOT NUMBER OF THE UNIT THAT CAUSED THE UTI AND IF IT WAS FROM THIS LOT. HE EXPERIENCED NO ROUGH EYELETS, BLEEDING, OR TRAUMA.

    Description of Event or Problem · 1

    INTERMITTENT CATHETER PATIENT (USER) REPORTED HE EXPERIENCED A URINARY TRACT INFECTION (UTI) CONCURRENT WITH CATHETER USE. THE PATIENT WAS PRESCRIBED AN ANTIBIOTIC FOR 3 DAYS, BUT THE INFECTION WAS NOT RESOLVED, AND WAS PRESCRIBED ANOTHER ANTIBIOTIC FOR 15 DAYS THAT HE TOOK, AND RECOVERED COMPLETELY FROM THE UTI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861281 CURE CATHETER URINARY CATHETER EZD CURE MEDICAL LLC M14 191120-2 008159947020048

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other