BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURE MEDICAL CATHETER INSERTION KIT

    MDR report key: 11711064 · Received April 22, 2021

    Report

    Report Number
    3005471919-2021-00040
    Event Type
    Injury
    Date Received
    April 22, 2021
    Date of Event
    December 1, 2020
    Report Date
    April 22, 2021
    Manufacturer
    CURE MEDICAL LLC
    Product Code
    OHR
    UDI-DI
    00815947020468
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DURING FOLLOW-UP, THE PATIENT SAID SHE HAD USED THE CATHETER FROM ANOTHER MANUFACTURER AND THE K1 KITS FOR OVER FOUR YEARS WITHOUT A PROBLEM. SHE REPORTED THAT HER DOCTOR THOUGHT THE INFECTION MAY BE RELATED TO HER MEDICAL SUPPLIES AND CATHETERIZATION. SHE NOTICED IN (B)(6) 2021 THAT A FEW UNITS OF K1 KITS HAD SOME "SAND LIKE" DEBRIS LIKE "GREY SILVER SPECKS" WHEN SHE OPENED THE PACKAGE THAT FELL OUT AND SOME DISCOLORATION OF THE GLOVES. SHE DID NOT USE THE KITS AFTER DISCOVERING THOSE UNITS AND PREFERS TO NOT USE THE K1 KITS AGAIN. THE PATIENT HAD THE SUSPECT GLOVES TO RETURN BUT DECIDED NOT TO RETURN THEM AND DISCARDED THE PROBLEM UNITS. THE PATIENT ALSO PROVIDED ANOTHER LOT NUMBER, 19307801, BUT WAS UNABLE TO CONFIRM THE LOT NUMBER OF THE K1 KIT WITH THE GLOVES SHE WAS USING AT THE TIME OF THE INFECTION AND IF IT WAS FROM THIS LOT.

    Description of Event or Problem · 1

    INTERMITTENT CATHETER PATIENT (USER) SAID SHE GOT A URINARY TRACT INFECTION (UTI) AND HAS BEEN SICK FOR SIX MONTHS CONCURRENT WITH USE OF A CATHETER FROM ANOTHER MANUFACTURER BUT THINKS IT IS FROM USING GLOVES FROM A CURE MEDICAL BRAND CATHETER KIT (GLOVES, BZK WIPE, COLLECTION BAG, MATTRESS PROTECTOR, LUBRICATING JELLY). SHE NOTICES THE GLOVES HAVE HAD A BLACK SUBSTANCE ON OR IN THE GLOVES - MORE THAN DUST - LOOKS LIKE IT WAS WET, DRIED, AND THEN FLAKED OFF. THE BLACK SUBSTANCE IS EMBEDDED IN THE RIM OF THE GLOVE. THE PATIENT SAID THE BACTERIA IS RARE ACCORDING TO HER DOCTOR WHO CANNOT TELL WHERE IT IS COMING FROM BUT KNOWS IT IS CATHETER RELATED. DURING FOLLOW-UP, THE PATIENT SAID WAS PRESCRIBED A DOSE OF BACTRIM, THEN A SECOND AND THIRD DOSE, BUT THE INFECTION WAS NOT RESOLVED. SHE WAS THEN PLACED ON BACTRIM AS A MAINTENANCE ANTIBIOTIC THAT RESOLVED THE INFECTION AND FEELS FINE NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606535 CURE MEDICAL CATHETER INSERTION KIT CATHETER CARE TRAY OHR CURE MEDICAL LLC K1 19306401 00815947020468

    Patients

    Seq Age Sex Outcome Treatment
    1 Other