BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUMAVEL DOSEPRO

    MDR report key: 1750179 · Received July 5, 2010

    Report

    Report Number
    MW5016626
    Event Type
    Injury
    Date Received
    July 5, 2010
    Date of Event
    June 20, 2010
    Report Date
    July 5, 2010
    Manufacturer
    ZOGENIX
    Product Code
    KZE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FOLLOWING USE OF SUMAVEL DOSEPRO I HAD SLIGHT ECHO PROBLEM IN THE RIGHT EAR. I AGAIN USED THE SUMAVEL ON WEDNESDAY, (B)(6). SEVERAL HOURS LATER I LOST THE HEARING IN MY RIGHT EAR. I READ THE INFO SHEET ON THE MEDICATION AND IT INDICATED THERE WERE EAR PROBLEMS IN THE TRIALS. THE DOCTOR HAS TOLD ME I HAVE TOTAL LOSS OF HEARING AND CAN SEE NO REASONS WHY. COULD YOU GIVE ME ADDITIONAL INFO REGARDING THE LOSS OF HEARING DURING THE TRIAL USAGE? DOSE OR AMOUNT: ONE DOSE, ONCE A DAY, AS NEEDED. DATES OF USE: #1: (B)(6) 2010; #2: (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: MIGRAINE HEADACHES. SUMAVEL DOSEPRO USED TWO DOSES (B)(6), (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUMAVEL DOSEPRO 6MG/ 0.5-ML NEEDLE-FREE DELIVERY SYSTEM KZE ZOGENIX 109381

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other