BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONY CRE-C20 RECHARGEABLE SELF-FITTING OTC HEARING AIDS

    MDR report key: 21240532 · Received January 27, 2025

    Report

    Report Number
    MW5165211
    Event Type
    Malfunction
    Date Received
    January 27, 2025
    Date of Event
    January 17, 2025
    Report Date
    January 19, 2025
    Manufacturer
    SONY CORPORATION/WS AUDIOLOGY DENMARK A/S
    Product Code
    QUH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE HEARING AIDS KEPT FALLING OUT OF MY EARS. I HAD TO KEEP REINSERTING THEM EVERY TIME I TRIED TO WEAR THEM. EVENTUALLY, I LOST THE LEFT HEARING AID. I DIDN'T KNOW THAT IT WAS GONE UNTIL I REALIZED I WASN'T HEARING AS WELL ON THE LEFT SIDE. WHEN I CHECKED MY LEFT EAR, I FOUND OUT IT WASN'T THERE. I SEARCHED EVERYWHERE IN THE ROOM I WAS IN, OUTSIDE THE BUILDING, AND INSIDE THE CAR. I SEARCHED AT HOME TOO; I HAVEN'T LOCATED IT YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1607201 SONY CRE-C20 RECHARGEABLE SELF-FITTING OTC HEARING AIDS SELF-FITTING AIR-CONDUCTION HEARING AID, OVER THE COUNTER QUH SONY CORPORATION/WS AUDIOLOGY DENMARK A/S

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female ACETAMINOPHEN AS NEEDED ACCORDING TO CONTAINER DIRECTIONS| ARIPIPRAZOLE| BUPROPION| DULOXETINE| L-LYSINE| LEVOTHYROXINE| PROPRANOLOL| VITAMIN D3