BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVER THE EAR HEARING AIDS

    MDR report key: 18810760 · Received February 27, 2024

    Report

    Report Number
    MW5152178
    Event Type
    Injury
    Date Received
    February 27, 2024
    Date of Event
    February 22, 2024
    Report Date
    February 25, 2024
    Manufacturer
    MDHEARINGAID
    Product Code
    QUF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I PURCHASED OVER THE EAR HEARING AIDS FROM MDHEARING. AFTER A FEW DAYS OF WEARING THE HEARING AIDS I DEVELOPED A NASTY, CRUSTY SORE IN MY RIGHT EAR CANAL. I HAVE NOT GONE TO A DOCTOR. I HAVE DISCONTINUED USING THE HEARING AIDS AND HAVE REQUESTED THE RETURN OPTION VIA MDHEARING. SERIAL NUMBERS: (B)(6). UDI (UNIQUE DEVICE IDENTIFIER) NUMBER: "(B)(4)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297176 OVER THE EAR HEARING AIDS HEARING AID, AIR-CONDUCTION, OVER THE COUNTER QUF MDHEARINGAID A-AIR-3

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Other EQUATE ALLERGY RELIEF.| EQUATE EXTRA STRENGTH PAIN RELIEVER 500 MG.| OLLY XS SLEEP AID.| SIMVASTATIN 20MG.