BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHONAK "HEARING AID MASKERS"

    MDR report key: 4895179 · Received June 30, 2015

    Report

    Report Number
    MW5043596
    Event Type
    Injury
    Date Received
    June 30, 2015
    Manufacturer
    PHONAK
    Product Code
    KLW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SLEEPLESSNESS, INSOMNIA, DIARRHEA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422914 PHONAK "HEARING AID MASKERS" PHONAK "HEARING AID MASKERS" KLW PHONAK

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Disability IBUPROFEN 800MG TAB LEG| PROCTO FOAM HCL% AERMED| ESCI TAB PRAM 5 MG TAB IEV| QUETIAPINE FUMARATE 100MG TAB ACC| OPEPRAZOLE 20 MG CAP APO