BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OTICON

    MDR report key: 396493 · Received April 30, 2002

    Report

    Report Number
    MW4003300
    Event Type
    Malfunction
    Date Received
    April 30, 2002
    Date of Event
    October 1, 2001
    Report Date
    April 30, 2002
    Manufacturer
    OTICON CORP
    Product Code
    ESD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE HEARING AID WON'T "TUNE" PROPERLY IN SPITE OF OVER 6 TRIPS TO THE DISPENSER/DISTRIBUTOR. PT SAID THAT THE DEVICE WORKS BETTER AT VERY CLOSE RANGE AND FAR AWAY, BUT AT MID-RANGE (810 FEET) IT HAS PROBLEMS. COMPLAINANT WAS ALSO CONCERNED THAT BATTERIES ONLY LAST ABOUT 8 DAYS, INSTEAD OF A COUPLE WEEKS AS PROMOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OTICON HEARING AID ESD OTICON CORP NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO