BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWIST CATHETER

    MDR report key: 11986843 · Received June 11, 2021

    Report

    Report Number
    3005471919-2021-00052
    Event Type
    Injury
    Date Received
    June 11, 2021
    Date of Event
    April 12, 2021
    Report Date
    June 11, 2021
    Manufacturer
    CURE MEDICAL LLC
    Product Code
    KOD
    UDI-DI
    00815947020390
    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 HASN'T CHANGED HER CATHETERIZATION TECHNIQUE AT ALL, AND JUST TRIED THE T14 ABOUT TWO MONTHS AGO. SHE EXPLAINED THAT SHE IS VERY SENSITIVE TO MANY INGREDIENTS INCLUDING PARABENS, ONE OF THE MANY INGREDIENTS IN THE LUBRICANT OF THE T14. SHE CONCLUDED SHE MUST BE SENSITIVE TO THE LUBRICANT ON THE T14, BUT DIDN'T NOTICE IT SINCE SHE HAS NO SENSATION IN THAT AREA. SHE NOTICED NO DEFECT OR MALFUNCTION WITH THE T14 CATHETER.

    Description of Event or Problem · 1

    INTERMITTENT CATHETER PATIENT (USER) SAID SHE THINKS SHE GOT A URINARY TRACT INFECTION (UTI) FROM A CATHETER, AS SHE HASN'T HAD A UTI SINCE 2014. SHE NOW HAS HAD TWO UTI'S IN THE LAST MONTH AND IS ON MEDICATION. SHE THINKS IT COULD BE SOMETHING IN THE LUBRICANT THAT MAY HAVE CAUSED THE UTI. DURING FOLLOW-UP, THE PATIENT SAID SHE WAS PRESCRIBED AN ANTIBIOTIC AND TOOK THE FULL COURSE, BUT THE INFECTION WAS NOT RESOLVED. SHE WAS PRESCRIBED ANOTHER ANTIBIOTIC AND JUST FINISHED THE DOSE. SHE FEELS FINE AND WILL VISIT HER DOCTOR TO CONFIRM THE INFECTION WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    880554 TWIST CATHETER URINARY CATHETER KOD CURE MEDICAL LLC T14 200115-2 00815947020390

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other