BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURE CATHETER HYDROPHILIC COATED

    MDR report key: 10121658 · Received June 4, 2020

    Report

    Report Number
    3005471919-2020-00039
    Event Type
    Injury
    Date Received
    June 4, 2020
    Date of Event
    April 6, 2020
    Report Date
    June 4, 2020
    Manufacturer
    CURE MEDICAL LLC
    Product Code
    EZD
    UDI-DI
    00815947020345
    PMA / PMN Number
    K132500
    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 KNOW IF THE HM14C CATHETER CONTRIBUTED TO THE UTI. HE SAID HE NOTICED NO DEFECT OR MALFUNCTION WHEN USING IT, AND EXPERIENCED NO PAIN, BLEEDING, OR TRAUMA OF ANY SORT. SINCE THERE WERE NO PRODUCT DEFECTS OR MALFUNCTION, THE PATIENT DID NOT THINK THERE WAS A NEED TO RETURN THE CATHETERS FROM LOT 191008-3.

    Description of Event or Problem · 1

    INTERMITTENT CATHETER PATIENT (USER) STATED HE IS AFRAID TO USE TO USE THE CATHETERS AS HE GOT A URINARY TRACT INFECTION (UTI) WHILE USING THE HM14C CATHETER. DURING FOLLOW-UP, THE PATIENT SAID HE WAS PRESCRIBED AN ANTIBIOTIC BY HIS DOCTOR, TOOK THE FULL COURSE, AND RECOVERED FULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585393 CURE CATHETER HYDROPHILIC COATED URINARY CATHETER EZD CURE MEDICAL LLC HM14C 191008-3 00815947020345

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other