BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOFRIC PRIMO

    MDR report key: 3181323 · Received June 14, 2013

    Report

    Report Number
    3009632672-2013-00007
    Event Type
    Injury
    Date Received
    June 14, 2013
    Report Date
    March 16, 2011
    Manufacturer
    WELLSPECT HEALTHCARE
    Product Code
    GBM
    PMA / PMN Number
    K050874
    Adverse Event
    Yes
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SUBMISSION IS BEING MADE AFTER AN ACQUISITION AND INTERNAL AUDIT OF WELLSPECT HEALTHCARE. ANALYSIS OF THE SAMPLES RETURNED SHOW NO DEFECTS OR DEVIATIONS. BASED UPON THE PRODUCT TESTING, THIS COMPLAINT COULD NOT BE CONFIRMED AS REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINS THAT THE CATHETER SURFACE IS ROUGH AND HAS CAUSED BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271222 LOFRIC PRIMO CATHETER, URETHRAL, GBM GBM WELLSPECT HEALTHCARE 96012 82993

    Patients

    Seq Age Sex Outcome Treatment
    1 Other