BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GNRESOUND

    MDR report key: 2093895 · Received May 12, 2011

    Report

    Report Number
    MW5020601
    Event Type
    Malfunction
    Date Received
    May 12, 2011
    Report Date
    May 12, 2011
    Manufacturer
    GNRESOUND
    Product Code
    KLW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I PURCHASED GNRESOUND PULSE HEARING AIDS IN 2007. THESE WERE SOLD AS A RECHARGEABLE PRODUCT. THE CHARGING UNIT HAS NEVER WORKED. I WAS TOLD REPEATEDLY THAT THIS WAS A USER ERROR ISSUE. I HAVE RECENTLY FOUND OUT THAT THE PRODUCT WAS DROPPED BECAUSE IT WAS FAULTY. THE COMPANY HAS NEVER NOTIFIED ME THAT THERE IS IN FACT A PRODUCT PROBLEM OR OFFERED ANY FORM OF COMPENSATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GNRESOUND PULSE KLW GNRESOUND

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR