BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BTE HEARING AID

    MDR report key: 18660951 · Received February 6, 2024

    Report

    Report Number
    MW5151140
    Event Type
    Malfunction
    Date Received
    February 6, 2024
    Date of Event
    January 30, 2024
    Report Date
    February 4, 2024
    Manufacturer
    AUDIEN HEARING / BUDGET HEARING AIDS LLC
    Product Code
    QUF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I WAS INSERTING THE RECEIVER FOR MY LEFT HEARING AID INTO MY EAR. AS I WAS PUTTING IT INTO THE EAR CANAL THE WIRE ATTACHING IT TO THE BEHIND THE EAR PORTION OF THE HEARING AID BROKE OFF FLUSH WITH THE RECEIVER. BECAUSE THE RECEIVER WAS NOT FULLY INSERTED INTO THE EAR CANAL I WAS ABLE TO REMOVE IT WITHOUT MEDICAL ASSISTANCE. ONCE FULLY INSERTED IN THE CANAL, IT WOULD BE BEYOND REACH WITHOUT A MEDICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809602 BTE HEARING AID HEARING AID, AIR-CONDUCTION, OVER THE COUNTER QUF AUDIEN HEARING / BUDGET HEARING AIDS LLC BTE BTE01

    Patients

    Seq Age Sex Outcome Treatment
    1