BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOFRIC ORIGO

    MDR report key: 3121924 · Received May 15, 2013

    Report

    Report Number
    3009632672-2013-00004
    Event Type
    Injury
    Date Received
    May 15, 2013
    Report Date
    April 18, 2013
    Manufacturer
    WELLSPECT HEALTHCARE
    Product Code
    EZD
    PMA / PMN Number
    K122078
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACTUAL DEVICES RETURNED. SINCE THE SAMPLES RETURNED HAVE BEEN USED, THE COATING ON THE CATHETER IS NO LONGER AVAILABLE FOR EVALUATION. THE CATHETERS RETURNED HAVE BEEN ANALYZED AND SHOW 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

    DISCOMFORT. TWO PTS EXPERIENCED THE CATHETER STICKING WHEN THEY PULLED IT OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214659 LOFRIC ORIGO UROLOGICAL CATHETER AND ACCESSORIES, EZD EZD WELLSPECT HEALTHCARE 44312 AND 44314 129958 AND 131679

    Patients

    Seq Age Sex Outcome Treatment
    1 Other