BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENRICH PRO ITC

    MDR report key: 18639574 · Received February 5, 2024

    Report

    Report Number
    2523532-2024-00001
    Event Type
    Malfunction
    Date Received
    February 5, 2024
    Date of Event
    January 23, 2024
    Report Date
    February 5, 2024
    Manufacturer
    SOUND QUEST, LLC
    Product Code
    QUF
    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, I BOUGHT A PAIR OF LUCID HEARING AIDS ABOUT A YEAR AND A HALF AGO FROM SAM'S CLUB. THEY WORKED GREAT FOR A LITTLE WHILE AND STOPPED WORKING. I PURCHASED ANOTHER PAIR ABOUT A MONTH AND A HALF AGO AND ACTUALLY HAD IT BREAK OFF IN MY EAR WITH THE RUBBER PIECE, STILL ON IT AND HAD TO HAVE IT REMOVED FROM MY EAR CANAL, AND AS I WAS PULLING THE OTHER ONE OUT HAD THE WHOLE TOP OF THE HEARING AID COME OFF. CUSTOMER DID NOT REQUIRE MEDICAL ATTENTION OR INVERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1621353 ENRICH PRO ITC HEARING AID, AIR-CONDUCTION, OVER THE COUNTER, QUF SOUND QUEST, LLC 10078

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose