BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWIST CATHETER

    MDR report key: 11822286 · Received May 13, 2021

    Report

    Report Number
    3005471919-2021-00047
    Event Type
    Injury
    Date Received
    May 13, 2021
    Date of Event
    March 1, 2021
    Report Date
    May 13, 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 SHE THINKS SHE ACQUIRED THE INFECTION DUE TO HER REUSE OF CATHETERS. SHE DID NOT GET HER SUPPLIES ON TIME AND HAS BEEN HAVING TO REUSE THE CATHETERS. SHE SAID THERE HAVE NEVER BEEN ANY DEFECTS OR MALFUNCTION OR ANY PROBLEMS WITH THE T12 CATHETERS.

    Description of Event or Problem · 1

    INTERMITTENT CATHETER PATIENT (USER) SAID SHE GOT A URINARY TRACT INFECTION (UTI) CONCURRENT WITH CATHETER USE. DURING FOLLOW-UP, THE PATIENT SAID SHE HAS NOT BEEN ABLE TO RESOLVE THE INFECTION BECAUSE SHE HAS MULTIPLE SCLEROSIS (MS) AND IS LIMITED IN THE ANTIBIOTICS SHE CAN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717083 TWIST CATHETER URINARY CATHETER KOD CURE MEDICAL LLC T12

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other