BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARING AID

    MDR report key: 12576547 · Received October 4, 2021

    Report

    Report Number
    MW5104388
    Event Type
    Malfunction
    Date Received
    October 4, 2021
    Date of Event
    January 1, 2021
    Report Date
    October 4, 2021
    Manufacturer
    STARKEY LABORATORIES, INC.
    Product Code
    ESD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    THE CAREGIVER CALLED TO REPORT THAT THE PATIENTS HEARING AID HAS BEEN HACKED AND IS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1464358 HEARING AID HEARING AID, AIR CONDUCTION ESD STARKEY LABORATORIES, INC. 730

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other