BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURE CATHETER

    MDR report key: 11891294 · Received May 26, 2021

    Report

    Report Number
    3005471919-2021-00050
    Event Type
    Injury
    Date Received
    May 26, 2021
    Date of Event
    April 21, 2021
    Report Date
    May 26, 2021
    Manufacturer
    CURE MEDICAL LLC
    Product Code
    EZD
    UDI-DI
    008159947020048
    PMA / PMN Number
    K072539
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DURING FOLLOW-UP, THE PATIENT REPORTED A SMALL AMOUNT OF BLOOD CLOT FROM ABOUT ONE TO TWO DROPS OF BLOOD, THEN THERE IS CLEAR URINE, THEN BLOOD WHEN HE REMOVES THE CATHETER. HIS DOCTOR SUGGESTED THAT THE PATIENT GOES DOWN IN SIZE TO A 10 FRENCH CATHETER, BUT BOTH THE PATIENT AND HIS DOCTOR ARE UNSURE AS TO THE EXACT CAUSE OF THE BLEEDING.

    Description of Event or Problem · 1

    INTERMITTENT CATHETER PATIENT (USER) REPORTED BLEEDING AND STATED HE WENT TO HIS DOCTOR AFTER SEEING INITIAL BLEEDING AND FOUND OUT HE HAD A URINARY TRACT INFECTION (UTI) CONCURRENT WITH CATHETER USE. HE WAS PUT ON ANTIBIOTICS AND REPORTED THE BLEEDING SEEMS TO BE SLOWING DOWN NOW, BUT STILL BLEEDS EVERY TIME HE USES THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786710 CURE CATHETER URINARY CATHETER EZD CURE MEDICAL LLC M12 200709-2 008159947020048

    Patients

    Seq Age Sex Outcome Treatment
    1 Other