BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISHER WALLACE CRANIAL NEUROSTIMULATOR

    MDR report key: 16862010 · Received May 3, 2023

    Report

    Report Number
    3006258094-2023-00041
    Event Type
    Malfunction
    Date Received
    May 3, 2023
    Report Date
    February 2, 2023
    Manufacturer
    FISHER WALLACE LABS
    Product Code
    QJQ
    PMA / PMN Number
    K903654
    Removal / Correction Number
    RES 91982
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    HELLO, I SENT OUT AN EMAIL LAST WEEK REGARDING THE PADS REPLACEMENT. THANK YOU FOR THE NEW ONES. I'M HAVING ISSUES WITH THE CONTROL. I REPLACED THE BATTERIES AND IT HEATED UP, AND IT SMELLED LIKE BURNING PLASTIC SO I REMOVED THE BATTERY AGAIN. CAN THE CONTROL BE REPLACED TOO?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    811244 FISHER WALLACE CRANIAL NEUROSTIMULATOR CRANIAL NEUROSTIMULATOR QJQ FISHER WALLACE LABS FW-100

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other