BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WANDER GUARD

    MDR report key: 3112274 · Received June 23, 2006

    Report

    Report Number
    3112274
    Event Type
    Malfunction
    Date Received
    June 23, 2006
    Date of Event
    May 29, 2006
    Report Date
    June 22, 2006
    Manufacturer
    SENIOR TECHNOLOGIES
    Product Code
    KMI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RESIDENT/PATIENT WEARING A WANDER GUARD BRACELET WENT OUTSIDE OF BUILDING THROUGH FRONT DOOR. WANDER GUARD SYSTEM DID NOT SOUND WHEN RESIDENT WENT OUTSIDE BUILDING OR COMING BACK INSIDE OF BUILDING AS INTENDED TO DO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WANDER GUARD SENIOR TECHNOLOGIES KMI SENIOR TECHNOLOGIES 32013, 34012

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR