BEUDAMED
    FDA Adverse Event Summary report: N

    TURBO EAR SOUND AMPLIFIER

    MDR report key: 7269561 · Received February 13, 2018

    Report

    Report Number
    MW5075221
    Date Received
    February 13, 2018
    Date of Event
    February 1, 2017
    Report Date
    February 13, 2018
    Manufacturer
    GOLDEN AIM INTERNATIONAL LTD.
    Product Code
    ESD
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CALLER STATED SHE AND HER BROTHER PURCHASED THE TURBO EAR AMPLIFIER FROM (B)(6). BOTH DEVICES WERE FOUND TO BE DEFECTIVE. THE CALLER AND HER BROTHER CANNOT HEAR WITH THEIR DEVICES DUE TO BACKGROUND NOISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112440 TURBO EAR SOUND AMPLIFIER HEARING AID, AIR CONDUCTION ESD GOLDEN AIM INTERNATIONAL LTD. 18862MSA30X
    112441 TURBO EAR SOUND AMPLIFIER HEARING AID, AIR CONDUCTION ESD GOLDEN AIM INTERNATIONAL LTD. 18862MSA30X

    Patients

    Seq Age Sex Outcome Treatment
    1