BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOFRIC PRIMO MALE CH12

    MDR report key: 3181386 · Received June 14, 2013

    Report

    Report Number
    3009632672-2013-00005
    Event Type
    Injury
    Date Received
    June 14, 2013
    Report Date
    May 26, 2011
    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. NEITHER ANALYSIS OF THE SAMPLES RETURNED NOR THE BATCH DOCUMENTATION REVEALS ANY PRODUCT DEFECTS OR DEVIATIONS. BASED UPON THE PRODUCT TESTING, THIS COMPLAINT COULD NOT BE CONFIRMED AS REPORTED.

    Description of Event or Problem · 1

    A PATIENT IS COMPLAINING ABOUT IRRITATION/DISCOMFORT WHEN USING THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270660 LOFRIC PRIMO MALE CH12 CATHETER URETHRAL, GBM GBM WELLSPECT HEALTHCARE 96012 83544, 86168

    Patients

    Seq Age Sex Outcome Treatment
    1 Other