BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOFRIC CH14

    MDR report key: 3181415 · Received June 14, 2013

    Report

    Report Number
    3009632672-2013-00009
    Event Type
    Injury
    Date Received
    June 14, 2013
    Report Date
    March 10, 2011
    Manufacturer
    WELLSPECT HEALTHCARE
    Product Code
    KOD
    PMA / PMN Number
    K896750
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SUBMISSION IS BEING MADE AFTER AN ACQUISITION AND INTERNAL AUDIT OF WELLSPECT HEALTHCARE. ACTUAL DEVICE RETURNED. SINCE THE SAMPLE RETURNED HAS BEEN USED, THE COATING ON THE CATHETER IS NO LONGER AVAILABLE FOR EVAL. THE CATHETER RETURNED HAS BEEN ANALYZED AND SHOWS NO DEFECTS. BATCH DOCUMENTATION HAS ALSO BEEN REVIEWED AND REVEALS NO DEVIATIONS. BASED ON THIS INFO THE COMPLAINT COULD NOT BE CONFIRMED AS REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINS ABOUT ROUGH SURFACE OF THE CATHETER. HE HAD A BLEEDING AFTER CATHETERIZATION AND WAS LATER ON DIAGNOSED WITH A UTI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271432 LOFRIC CH14 CATHETER UROLOGICAL, KOD KOD WELLSPECT HEALTHCARE 9014 80362

    Patients

    Seq Age Sex Outcome Treatment
    1 Other