BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOFRIC PRIMO

    MDR report key: 3181396 · Received June 14, 2013

    Report

    Report Number
    3009632672-2013-00015
    Event Type
    Injury
    Date Received
    June 14, 2013
    Report Date
    March 1, 2012
    Manufacturer
    WELLSPECT HEALTHCARE
    Product Code
    GBM
    PMA / PMN Number
    K050874
    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 EVALUATION. THE CATHETER RETURNED HAS BEEN ANALYZED AND SHOWS NO DEFECTS. BATCH DOCUMENTATION HAS ALSO BEEN REVIEWED AND REVEALS NO DEVIATIONS. BASED ON THIS INFORMATION, THE COMPLAINT COULD NOT BE CONFIRMED AS REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINS THE CATHETERIZATION IS PAINFUL AND HE NOTICED SOME BLOOD AFTER CATHETERIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272004 LOFRIC PRIMO CATHETER URETHRAL, GBM GBM WELLSPECT HEALTHCARE 96012 95466

    Patients

    Seq Age Sex Outcome Treatment
    1 Other