BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY UNIVERSAL 128CH WL ANDROID BLACK

    MDR report key: 21182152 · Received January 17, 2025

    Report

    Report Number
    2523532-2025-00001
    Event Type
    Malfunction
    Date Received
    January 17, 2025
    Date of Event
    December 19, 2024
    Report Date
    January 17, 2025
    Manufacturer
    SOUND QUEST, LLC
    Product Code
    OSM
    UDI-DI
    00812944028442
    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, CUSTOMER VISITED OUR CLINIC REPORTING DISCOMFORT AND A BURN ON THE EAR, WHICH THE CUSTOMER ATTRIBUTED TO THE HEARING AID. UPON EVALUATION BY THE CLINICIAN, IT WAS DETERMINED THAT THE BURN ON THE BACK OF THE EAR WAS CAUSED BY A LEAKING HEARING AID BATTERY, RESULTING IN A CHEMICAL BURN. THE CUSTOMER STATED THAT THEY PLAN TO CONSULT A PHYSICIAN REGARDING THE INJURY. THE HEARING AID WAS RECEIVED AT THE IMPORTER ON (B)(6)2025, BUT THE BATTERY WAS NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1057068 LIBERTY UNIVERSAL 128CH WL ANDROID BLACK HEARING AID, AIR-CONDUCTION WITH WIRELESS TECHNOLOGY, PRESCRIPTION OSM SOUND QUEST, LLC 5460 00812944028442

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male