BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENRICH PRO ITC

    MDR report key: 17710901 · Received September 8, 2023

    Report

    Report Number
    2523532-2023-00002
    Event Type
    Malfunction
    Date Received
    September 8, 2023
    Report Date
    September 7, 2023
    Manufacturer
    SOUND QUEST, LLC
    Product Code
    QUF
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT OR OTHER INFORMATION SUBMITTED BY (B)(4) 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, HEARING AID POPPED UP OUT OF THERE. IT WAS IN MY (THE END USER) EAR AND I LOOKED THAT THING JUST CAME OUT. I (THE END USER) CAN SEE THE WIRING ON THE INSIDE. PER THE IMPORTER, THE FACEPLATE SEPARATED FROM THE HOUSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1501535 ENRICH PRO ITC HEARING AID, AIR-CONDUCTION, OVER THE COUNTER QUF SOUND QUEST, LLC 10078

    Patients

    Seq Age Sex Outcome Treatment
    1 Female