BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOFRIC HYDROKIT

    MDR report key: 3181424 · Received June 14, 2013

    Report

    Report Number
    3009632672-2013-00023
    Event Type
    Injury
    Date Received
    June 14, 2013
    Report Date
    January 9, 2012
    Manufacturer
    WELLSPECT HEALTHCARE
    Product Code
    GBM
    PMA / PMN Number
    K043241
    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. THE PRODUCT WAS NOT AVAILABLE TO BE RETURNED. 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 ADD'L INFO BE RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINS ABOUT DISCOMFORT WHEN USING THE CATHETER. THE CUSTOMER HAD A BLEEDING AFTER CATHETERIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271435 LOFRIC HYDROKIT CATHETER, URETHRAL, GBM GBM WELLSPECT HEALTHCARE 98312 87887

    Patients

    Seq Age Sex Outcome Treatment
    1 Other