BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOFRIC PRIMO

    MDR report key: 3181397 · Received June 14, 2013

    Report

    Report Number
    3009632672-2013-00016
    Event Type
    Injury
    Date Received
    June 14, 2013
    Report Date
    June 22, 2012
    Manufacturer
    WELLSPECT HEALTHCARE
    Product Code
    EZD
    PMA / PMN Number
    K122078
    Adverse Event
    Yes
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SUBMISSION IS BEING MADE AFTER AN ACQUISITION AND INTERNAL AUDIT OF WELLSPECT HEALTHCARE. NO SAMPLES HAVE BEEN RETURNED. BATCH DOCUMENTATION HAS BEEN ANALYZED AND SHOWS NO DEVIATIONS. WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, WELLSPECT HEALTHCARE IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINS ABOUT THE CATHETERS BEING DIFFICULT TO INSERT. AFTER A CATHETERIZATION THERE WAS BLOOD ON THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271504 LOFRIC PRIMO CATHETER STRAIGHT, EZD EZD WELLSPECT HEALTHCARE 41012 100258

    Patients

    Seq Age Sex Outcome Treatment
    1 Other