BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONY CRE-E10 RIGHT

    MDR report key: 19557666 · Received June 17, 2024

    Report

    Report Number
    MW5156308
    Event Type
    Injury
    Date Received
    June 17, 2024
    Date of Event
    June 12, 2024
    Report Date
    June 13, 2024
    Manufacturer
    WS AUDIOLOGY USA, INC.
    Product Code
    QDD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    WHEN USING THE HEARING DEVICE I BEGAN HEARING A LOUD POPPING NOISE AND THEN MY LEFT EAR DRUM PRETTY SORE AND MUFFLED. WITH AN ENDOSCOPE I NOTICED A LARGE BLACK OPENING ON MY EAR DRUM CAUSED BY THE HEARING DEVICE. REF REPORT: MW5156309.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1654675 SONY CRE-E10 RIGHT SELF-FITTING AIR-CONDUCTION HEARING AID, PRESCRIPTION QDD WS AUDIOLOGY USA, INC. CRE-E10

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Male Required Intervention