BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURE MALE ULTRA

    MDR report key: 8783128 · Received July 11, 2019

    Report

    Report Number
    3005471919-2019-00048
    Event Type
    Injury
    Date Received
    July 11, 2019
    Date of Event
    May 22, 2019
    Report Date
    July 11, 2019
    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

    PATIENT REPORTED HE WAS USING ANOTHER BRAND OF CATHETER CONCURRENT WITH THE CURE MEDICAL BRAND DURING THE TIME OF THE EVENT AND HE EXPERIENCED BLEEDING WITH BOTH BRANDS. GIVEN THE TWO BRANDS OF DEVICES WERE USED CONCURRENTLY THERE IS NO WAY TO DETERMINE IF THE CURE MEDICAL DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. PATIENT REPORTED POSSIBLE SUSPECT PRODUCT LOTS BASED ON ITEMS IN HIS OWN STOCK. THE PATIENT DOES NOT KNOW WHICH LOT WAS USED WHEN THE INFECTION WAS CONTRACTED AND BLEEDING OCCURRED. THESE ARE THE POSSIBLE SUSPECT LOTS REPORTED: ITEM: ULTRA M14C, LOT: 180115-3, EXPIRES: 12-28-2020, MANUFACTURE DATE: 01-15-2018, UDI: (B)(4). ITEM: ULTRA M14C, LOT: 181119-1, EXPIRES: 10-28-2021, MANUFACTURE DATE: 11-19-2018, UDI: (B)(4).

    Description of Event or Problem · 1

    PATIENT (USER) REPORTED HE EXPERIENCED BLEEDING AND ACQUIRED A URINARY TRACT INFECTION (UTI) CONCURRENT WITH CATHETER USE. NO PRODUCT PROBLEM WAS REPORTED. PATIENT RELAYED THAT HIS DOCTOR SAID CATHETERS WERE CAUSING BLEEDING BY PERHAPS SCRAPING TISSUE FROM THE PROSTATE SURGERY WOUND ON THE WAY TO THE BLADDER. PATIENT WAS PRESCRIBED AN ANTIBIOTIC. AT TIME OF LAST FOLLOW UP PATIENT WAS AWAITING TEST RESULTS TO CONFIRM INFECTION WAS GONE. PATIENT NO LONGER REQUIRES CATHETERIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576665 CURE MALE ULTRA URINARY CATHETER KOD CURE MEDICAL LLC ULTRA M14C

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other