BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY UNIVERSAL 128CH WIRELESS BEIGE

    MDR report key: 19853487 · Received July 29, 2024

    Report

    Report Number
    2523532-2024-00002
    Event Type
    Malfunction
    Date Received
    July 29, 2024
    Date of Event
    June 26, 2024
    Report Date
    July 29, 2024
    Manufacturer
    SOUND QUEST, LLC
    Product Code
    OSM
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT OR OTHER INFORMATION SUBMITTED BY HEARING LAB TECHNOLOGY LLC UNDER 21 CFR PART 803, AND RELEASE BY FDA OF THAT REPORT INFORMATION, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY HEARING LAB TECHNOLOGY LLC, ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES, FINISHED DEVICE SUPPLIERS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO THE IMPORTER, BY THE END USER, THE CUSTOMER WAS TRAVELING FOR WORK AND HE FELT HIS RIGHT EAR GET EXTREMELY HOT AND FELT LIKE A STING. HE REMOVED HIS HEARING AID AND NOTICED SOME DARK DISCOLORATION ON THE HA AROUND THE EXTERIOR SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371390 LIBERTY UNIVERSAL 128CH WIRELESS BEIGE HEARING AID, AIR-CONDUCTION WITH WIRELESS TECHNOLOGY, PRESCRIPTION OSM SOUND QUEST, LLC 5570

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male