BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIVONGO SCALE

    MDR report key: 11762175 · Received May 3, 2021

    Report

    Report Number
    3011196194-2021-00008
    Event Type
    Malfunction
    Date Received
    May 3, 2021
    Date of Event
    April 3, 2021
    Report Date
    April 29, 2021
    Manufacturer
    LIVONGO HEALTH INC
    Product Code
    FRI
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SCALE WAS REQUESTED FOR RETURN TO THE MANUFACTURER FOR INVESTIGATION. HOWEVER, WE HAVE NOT RECEIVED THE DEVICE BACK FOR INVESTIGATION. NO INJURY TO THE USER WAS REPORTED.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THE BATTERIES INSIDE OF THEIR SCALE BECAME HOT AND STARTED TO PEEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663785 LIVONGO SCALE SCALE FRI LIVONGO HEALTH INC BT004L

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR