BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXI TRANSPONDER

    MDR report key: 215146 · Received March 18, 1999

    Report

    Report Number
    MW1015938
    Event Type
    Injury
    Date Received
    March 18, 1999
    Date of Event
    March 2, 1999
    Report Date
    March 11, 1999
    Manufacturer
    EXI
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NURSE CARING FOR INFANT WENT TO CLIP END OF CORD CLAMP (OPPOSITE END FROM WHERE PLASTIC CIRCULAR AREA SURROUNDS TRANSPONDER) TO OPEN IT. AS SHE DID SO, THE PLASTIC RIM OF THE TRANSPONDER POPPED (BROKE) OFF. IN THIS INFANT AND IN SEVERAL OTHER INFANTS, THE TRANSPONDER IS CAUSING PREMATURE DISLODGING OF THE CORD AT THE UMBILICUS WITH LOCAL BLEEDING WHICH HAS BEEN CONTROLLED WITH DIRECT PRESSURE. RETURNED TO DISTRIBUTOR ON 3/11/99.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXI TRANSPONDER INFANT SECURITY SYSTEM EXI WTX INF *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention HOLLISTER UMBILICAL CLAMPS (CORD CLIPS).