BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOFRIC PRIMO MALE

    MDR report key: 3181426 · Received June 14, 2013

    Report

    Report Number
    3009632672-2013-00017
    Event Type
    Injury
    Date Received
    June 14, 2013
    Report Date
    April 4, 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. THREE SAMPLES FROM THREE DIFFERENT LOTS WERE RETURNED. ANALYSIS OF THE SAMPLES SHOWS NO PRODUCT DEFECTS. BATH DOCUMENTATION REVEALS NO DEVIATIONS. BASED UPON THE PRODUCT TESTING, THIS COMPLAINT COULD NOT BE CONFIRMED AS REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINS THAT THREE DIFFERENT CATHETERS FROM THREE DIFFERENT LOTS HAS CAUSED HIM TO BLEED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272051 LOFRIC PRIMO MALE CATHETER, URETHRAL, GBM GBM WELLSPECT HEALTHCARE 96012 94267, 96018, 92492

    Patients

    Seq Age Sex Outcome Treatment
    1 Other