BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWIST CATHETER

    MDR report key: 11742281 · Received April 28, 2021

    Report

    Report Number
    3005471919-2021-00042
    Event Type
    Injury
    Date Received
    April 28, 2021
    Date of Event
    March 27, 2021
    Report Date
    April 28, 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 THE T12 CATHETERS DID NOT CONTRIBUTE TO THE PROBLEM AND HAD NO DEFECTS OR MALFUNCTION. SHE REPORTED EXPERIENCING BLEEDING, A BAD UTI, AND AN INABILITY TO URINATE OR DRAIN HER BLADDER WHICH RESULTED IN THE HOSPITALIZATION. THE PATIENT ALSO REPORTED REUSE OF THE CATHETER THAT MAY HAVE CONTRIBUTED TO HER GETTING AN INFECTION.

    Description of Event or Problem · 1

    INTERMITTENT CATHETER PATIENT (USER) SAID SHE WAS IN THE HOSPITAL LAST WEEK WITH A URINARY TRACT INFECTION (UTI) AND SHE SAID THE DOCTOR SAID SHE HAS BEEN GETTING MULTIPLE UTI'S BECAUSE OF SELF-CATHETERIZATION. SHE ALSO SAID SHE'S EXPERIENCED SOME BLEEDING AND WAS UNABLE TO URINATE FOR TWO DAYS. DURING FOLLOW-UP, THE PATIENT SAID SHE WAS PRESCRIBED AN ANTIBIOTIC AND IS STILL TAKING IT, AND WILL BE FOLLOWING UP WITH HER DOCTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633138 TWIST CATHETER URINARY CATHETER KOD CURE MEDICAL LLC T12

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| O