BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENRICH PRO ITC

    MDR report key: 18005839 · Received October 25, 2023

    Report

    Report Number
    2523532-2023-00003
    Event Type
    Malfunction
    Date Received
    October 25, 2023
    Report Date
    October 25, 2023
    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, PATIENT WAS PULLING THE HEARING AID OUT OF THE EAR CANAL BY THE PULL STRING AND IT CAME APART. PATIENT SAID THEY HAD TO GET A FRIEND TO GET THE PART OF THE HEARING AID OUT OF THE EAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1433076 ENRICH PRO ITC HEARING AID, AIR-CONDUCTION, OVER THE COUNTER QUF SOUND QUEST, LLC 10078

    Patients

    Seq Age Sex Outcome Treatment
    1 Male