BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENTLECATH OTHER

    MDR report key: 21351405 · Received February 10, 2025

    Report

    Report Number
    3005778470-2025-00078
    Event Type
    Injury
    Date Received
    February 10, 2025
    Report Date
    January 21, 2025
    Manufacturer
    UNOMEDICAL S.R.O.
    Product Code
    KOD
    UDI-DI
    00768455145591
    PMA / PMN Number
    K172924
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. THIS COMPLAINT HAS BEEN EVALUATED. NO LOT NUMBER IS AVAILABLE. A DETAILED INVESTIGATION OR BATCH REVIEW CANNOT BE CONDUCTED. THEREFORE, THIS EVALUATION WILL BE CLOSED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER: REPORTING SITE: 1049092, MANUFACTURING SITE: 3005778470.

    Description of Event or Problem · 0

    END USER REPORTED UNKNOWN QTY, UNKNOWN MUS, UNKNOWN LOTS OVER THE PAST FEW YEARS - MULTIPLE UTIS WITH USE. SHE STATES SHE HAS BEEN CATHING FOR YEARS, DUE TO SCAR TISSUE IN HER URETHRA AS MD ADVISED CATHING 1 X A WEEK TO KEEP HER URETHRAL SCAR TISSUE DILATED. SHE SAID THROUGHOUT THE YEARS SHE HAD TO CATH AND WOULD CONSTANTLY GET UTIS - SHE COULD NOT NAME HOW MANY UTIS SHE HAD BUT IT WAS NEARLY EVERY MONTH OR A LITTLE LONGER THAN A MONTH. HER MAIN UTI SYMPTOM WAS A CONSTANT FEELING OF PRESSURE. SHE WOULD OFTEN GO TO URGENT CARES TO GET URINE SPECIMENS, GET DIAGNOSED WITH UTIS AND TREATMENTS WITH ANTIBIOTICS AND AT TIMES OVER THE COUNTER AZO. SHE WAS NEVER PLACED ON ANY PROPHYLACTIC ANTIBIOTICS. SHE STATED SHE IS NOT BLAMING THE CATHETER FOR HER UTIS. NO PHOTO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785045 GENTLECATH OTHER CATHETER, UROLOGICAL KOD UNOMEDICAL S.R.O. 501022 00768455145591

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female