BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWIST CATHETER

    MDR report key: 11181734 · Received January 15, 2021

    Report

    Report Number
    3005471919-2021-00007
    Event Type
    Injury
    Date Received
    January 15, 2021
    Date of Event
    November 7, 2020
    Report Date
    January 15, 2021
    Manufacturer
    CURE MEDICAL LLC
    Product Code
    KOD
    UDI-DI
    00815947020390
    PMA / PMN Number
    K080881
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DURING FOLLOW-UP, THE PATIENT SAID SHE NOTICED NO DEFECTS OR MALFUNCTION WITH THE T14 CATHETER, BUT WAS SENSITIVE TO THE LUBRICANT. SHE EXPERIENCED IRRITATION REPEATEDLY AND VISITED HER DOCTOR TO BE TESTED FOR UTI'S BUT FOUND NO INFECTION. SHE USES THE T14 CATHETER WHEN SHE GOES OUT, BUT A NON-LUBRICATED CATHETER WHEN SHE IS AT HOME. AFTER REMAINING AT HOME FOR SOME TIME DUE TO COVID-19 RULES, SHE DISCOVERED SHE HAD NO IRRITATION WHILE USING HER OTHER CATHETERS. SHE USES NO LUBRICANT WITH THEM. ONCE SHE BEGAN USING THE T14 AGAIN WHEN GOING OUT, SHE EXPERIENCED THE SAME IRRITATION AGAIN, AND ACQUIRED ONE UTI WHILE USING THE T14 CATHETER. THE PATIENT ALSO PROVIDED ANOTHER LOT NUMBER,191220-1, BUT WAS UNABLE TO CONFIRM THE LOT NUMBER OF THE UNIT THAT CAUSED THE UTI AND IF IT WAS FROM THIS LOT.

    Description of Event or Problem · 1

    INTERMITTENT CATHETER PATIENT (USER) SAID THE PRE-LUBRICATION OF THE CATHETER IS CAUSING URINARY TRACT INFECTIONS (UTI). DURING FOLLOW-UP, THE PATIENT SAID SHE WAS PRESCRIBED AN ANTIBIOTIC, TOOK THE FULL COURSE, BUT DID NOT RECOVER FROM THE INFECTION. SHE WAS GIVEN A SECOND COURSE OF A DIFFERENT ANTIBIOTIC, AND RECOVERED FULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74284 TWIST CATHETER URINARY CATHETER KOD CURE MEDICAL LLC T14 200228-2 00815947020390

    Patients

    Seq Age Sex Outcome Treatment
    1