BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WANDER GUARD SIGNALING DEVICE

    MDR report key: 15894361 · Received November 30, 2022

    Report

    Report Number
    MW5113560
    Event Type
    Injury
    Date Received
    November 30, 2022
    Date of Event
    November 26, 2022
    Report Date
    November 28, 2022
    Manufacturer
    STANLEY HEALTHCARE SOLUTIONS LINCOLN/STANLEY CONVERGENT SECURITY SOLUTIONS, INC.
    Product Code
    IQA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    501
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WGE PLUS, 90 DAY, 508 KHZ SIGNALING DEVICE FOR A WANDER GUARD SYSTEM DID NOT ALARM WHEN PATIENT EXITED FACILITY THROUGH THE WANDER GUARD SYSTEM. THE SIGNALING DEVICE WAS ACTIVATED AND WITHIN THE 90-DAY ACTIVATION PERIOD. THE WANDER GUARD SYSTEM WAS WORKING PROPERLY. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348879 WANDER GUARD SIGNALING DEVICE SYSTEM, ENVIRONMENTAL CONTROL, POWERED IQA STANLEY HEALTHCARE SOLUTIONS LINCOLN/STANLEY CONVERGENT SECURITY SOLUTIONS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention