BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOFRIC

    MDR report key: 3181418 · Received June 14, 2013

    Report

    Report Number
    3009632672-2013-00019
    Event Type
    Injury
    Date Received
    June 14, 2013
    Report Date
    October 15, 2012
    Manufacturer
    WELLSPECT HEALTHCARE
    Product Code
    KOD
    PMA / PMN Number
    K896750
    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. SAMPLES RETURNED HAVE BEEN ANALYZED AND NO DEFECTS OR DEVIATIONS COULD BE FOUND. BASED UPON THE PRODUCT TESTING, THIS COMPLAINT COULD NOT BE CONFIRMED AS REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER HAD A UTI AND IS COMPLAINING ABOUT THE SHARP CATHETER EYES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271433 LOFRIC CATHETER, UROLOGICAL, KOD KOD WELLSPECT HEALTHCARE 9014 96263

    Patients

    Seq Age Sex Outcome Treatment
    1 Other