BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOBERLINK CONNECT DEVICE

    MDR report key: 15499187 · Received September 27, 2022

    Report

    Report Number
    MW5112310
    Event Type
    Injury
    Date Received
    September 27, 2022
    Date of Event
    May 8, 2021
    Report Date
    September 24, 2022
    Manufacturer
    SOBERLINK HEALTHCARE LLC
    Product Code
    DJZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE DEVICE CONTINUOUSLY MALFUNCTIONED, RESULTING IN UNREPORTED TESTING REPORTS AND LOSS OF CUSTODY. CHILDREN WERE TRAUMATIZED. LENGTHY STRESSFUL AND EXPENSIVE LEGAL BATTLES ENSUED. IF USING THIS DEVICE, BE ABSOLUTELY CERTAIN TO UNDERSTAND THE LIMITATIONS OF THIS TECHNOLOGY. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2150896 SOBERLINK CONNECT DEVICE DEVICES, BREATH TRAPPING, ALCOHOL DJZ SOBERLINK HEALTHCARE LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Other SOBERLINK DEVICE