BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURE MALE ULTRA

    MDR report key: 11680501 · Received April 16, 2021

    Report

    Report Number
    3005471919-2021-00038
    Event Type
    Injury
    Date Received
    April 16, 2021
    Date of Event
    March 16, 2021
    Report Date
    April 16, 2021
    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 · 1

    DURING FOLLOW-UP, THE PATIENT SAID HE HAD DIFFICULTY WHEN INSERTING THE CATHETER AND ENDURED PAIN AND BLEEDING. THE PATIENT DID NOT WANT TO CONFIRM ANY DETAILS OF THE INITIAL REPORT OF THE ADVERSE EVENT FROM THE DEALER. HE WAS ADVISED TO ASK HIS DOCTOR ABOUT THE COUDE TIP CATHETER IF HE HAS PROBLEMS WITH INSERTION OR WITH A FALSE PASSAGE. HE SAID HE DID NOT EXAMINE THE CATHETER CLOSELY BEFORE USE AND DISCARDED IT SO HE HAD NONE TO RETURN.

    Description of Event or Problem · 1

    INTERMITTENT CATHETER PATIENT (USER) REPORTED TO HIS SUPPLIER LOTS OF BLOOD COMING OUT CONCURRENT WITH CATHETER USE AND DIDN'T KNOW IF IT'S THE EYELET SCRAPE OR FALSE PASSAGE. HE WENT TO THE HOSPITAL AND WAS ADVISED IT WAS A TEAR IN HIS URETHRA. DURING FOLLOW-UP, THE PATIENT SAID HE WAS TREATED AT THE HOSPITAL AND RELEASED THE SAME DAY. HE HAD TO BE PLACED ON A FOLEY CATHETER WITH A BAG AND WILL BE VISITING HIS UROLOGIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578337 CURE MALE ULTRA URINARY CATHETER KOD CURE MEDICAL LLC ULTRAM16

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other| R