BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOFRIC

    MDR report key: 3181414 · Received June 14, 2013

    Report

    Report Number
    3009632672-2013-00024
    Event Type
    Injury
    Date Received
    June 14, 2013
    Report Date
    March 19, 2012
    Manufacturer
    WELLSPECT HEALTHCARE
    Product Code
    EZD
    PMA / PMN Number
    K113424
    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. 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 ABOUT PROBLEMS INSERTING THE CATHETER. THE CUSTOMER HAS ALSO EXPERIENCED BLEEDING AFTER CATHETERIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272029 LOFRIC CATHETER, STRAIGHT, EZD EZD WELLSPECT HEALTHCARE 40014 96863

    Patients

    Seq Age Sex Outcome Treatment
    1 Other