BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPEEDICATH COMPACT MALE

    MDR report key: 12721350 · Received October 29, 2021

    Report

    Report Number
    3006606901-2021-00028
    Event Type
    Injury
    Date Received
    October 29, 2021
    Report Date
    October 29, 2021
    Manufacturer
    COLOPLAST A/S
    Product Code
    GBM
    UDI-DI
    05708932967150
    PMA / PMN Number
    K121458
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    27 CLOSED SAMPLES OF THIS LOT WERE TESTED. ALL SAMPLES MET PRODUCTION REQUIREMENTS. THE QUALITY ENGINEER CHECKED THE MANUFACTURING PROCESS RELATED TO THE GIVEN FINISHED GOODS LOT NUMBER AND NO NONCONFORMITIES WERE FOUND THAT WERE RELATED TO THIS EVENT. A REVIEW OF THE PRODUCTION DOCUMENTS DID NOT REVEAL ANY NON-CONFORMITY THAT ARE RELATED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    SPEEDICATH COMPACT MALE CATHETERS WITH A DIFFERENT LOT NUMBER WERE UTILIZED BY THE END USER (7781880). THIS LOT NUMBER WILL BE FILED UNDER A SEPARATE MFR#. WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. ONCE OUR EVALUATION IS COMPLETE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ACCORDING TO THE INFORMATION AVAILABLE, THE REPORTS CONCERNS A (B)(6) YEAR-OLD MALE END-USER WHO CATHETERIZED APPROXIMATELY ONCE EVERY NIGHT. ON FIVE OCCASIONS THE END-USER WAS NOT ABLE TO DRAIN URINE. AT THE LAST CATHETERIZATION THERE WAS NO URINE BUT THERE WAS SOME BLEEDING, WHICH DIDN¿T PERSIST. THE NEXT MORNING (B)(6) 2021 THE-END USER WAS CONFUSED, AND IN THE AFTERNOON, HE FELL AND HURT HIS HEAD. THE END-USER WAS THEN ADMITTED TO THE HOSPITAL DUE TO WEAKNESS. HE HAD A FEVER AND A URINARY TRACT INFECTION (UTI) AT ADMISSION (UTI, AND HE TESTED POSITIVE FOR KLEBSIELLA), BUT NO BLEEDING OR BLOOD INFECTION. HE WAS PLACED ON INDWELLING CATHETER AND ANTIBIOTICS. THE END-USER IS RECOVERING AND IS NOT PLANNING TO CONTINUE WITH INTERMITTENT CATHETERIZATION. THE WIFE PERFORMED THE CATHETERIZATIONS ACCORDING TO THE INSTRUCTION FOR USE (IFU), AND THEY DID NOT NOTICE ANY DAMAGE OR DEVIATIONS IN THE CATHETERS THEY USED. THE END-USER WAS ABLE TO CATHETERIZE DUE TO RESIDUAL URINE AND IS NEW TO INTERMITTENT CATHETERIZATION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1617319 SPEEDICATH COMPACT MALE SPEEDICATH COMPACT MALE GBM COLOPLAST A/S 2842211400 8098243 05708932967150

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Hospitalization