BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 215134 · Received March 18, 1999

    Report

    Report Number
    MW1015935
    Event Type
    Other
    Date Received
    March 18, 1999
    Date of Event
    February 1, 1999
    Report Date
    March 11, 1999
    Manufacturer
    DEI
    Product Code
    HFW
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFO RECEIVED 6/14/99: CO FEELS THAT THE SITUATIONS THAT OCCURRED ARE DUE TO PERSONNEL AT THE HOSP MODIFYING THE TOOL USED TO REMOVE THE TRANSPONDER TAGS. CO HAS SUPPLIED TWO NEW TRANSPONDER REMOVERS AT NO CHARGE TO ASSIST IN REMEDYING THIS CONCERN. HOWEVER, ULTIMATELY, CONCERNS REGARDING TOOL MODIFICATION OR IMPROPER USE OF THE TOOL SHOULD BE DIRECTED TO THE STAFF OF THE HOSP. CO HAS REPLACED SYSTEM COMPONENTS AT NO CHARGE, PROVIDED ADDITIONAL TRAINING AT NO CHARGE, AND HAD EVEN OFFERED TO REMOVE THE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * CLAMP CUTTER (FOR REMOVING TRANSPONDER) HFW DEI ESD SAFE *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other EXI TRANSPONDER INFANT SECURITY SYSTEM.