BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS HEARLINK

    MDR report key: 19097181 · Received April 11, 2024

    Report

    Report Number
    MW5153791
    Event Type
    Injury
    Date Received
    April 11, 2024
    Date of Event
    April 1, 2024
    Report Date
    April 10, 2024
    Manufacturer
    SBO HEARING A/S
    Product Code
    OSM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    HEARING AID STOPPED WORKING FROM ONE AND BOTH EARS UNPREDICTABLY. WON'T SYNC WITH AUTO OR LAPTOP OR PHONE INCLUDING WHILE DRIVING OR LISTENING TO SAFETY INSTRUCTIONS. HEARING AID USAGE IS ASSOCIATED WITH DECREASE DEPRESSION, INJURIES, AND ISOLATION. THE FAILURE OF THESE DEVICES CAN CAUSE SERIOUS ISSUES THAT AREN'T READILY APPARENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836789 PHILIPS HEARLINK HEARING AID, AIR-CONDUCTION WITH WIRELESS TECHNOLOGY, PRESCRIPTION OSM SBO HEARING A/S C 2B

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention