BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONE

    MDR report key: 865488 · Received June 12, 2007

    Report

    Report Number
    MW5002627
    Event Type
    Injury
    Date Received
    June 12, 2007
    Date of Event
    April 11, 2007
    Report Date
    June 12, 2007
    Manufacturer
    BSS, INC.
    Product Code
    ESD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PURCHASED HEARING AID FROM COMPANY. AID WAS DEFECTIVE AND THE FEEDBACK/AMPLIFIER WAS LOUD ENOUGH TO CAUSE PERMANENT HEARING DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE BTE HEARING AID ESD BSS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other