BEUDAMED
    FDA Adverse Event Other Summary report: N

    FISHER WALLACE STIMULATOR

    MDR report key: 2475545 · Received December 22, 2011

    Report

    Report Number
    3006258094-2011-00001
    Event Type
    Other
    Date Received
    December 22, 2011
    Report Date
    September 30, 2011
    Manufacturer
    FISHER-WALLACE LABORATORIES LLC
    Product Code
    JXK
    PMA / PMN Number
    K903654
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT / PERSON WHO FILED THIS REPORT WITH THE FDA NEVER RETURNED THE DEVICE TO THE MFR (OR IF THEY DID, HE/SHE NEVER IDENTIFIED THE ADVERSE EVENT IN CONNECTION WITH THEIR RETURN, MAKING DEVICE EVAL IMPOSSIBLE). THE PT REACTION DESCRIBED IN THE REPORT MAY BE DEEMED A "PARADOXICAL RESPONSE." DETERMINING IF THE DEVICE CONTRIBUTED TO THE SYMPTOMS REQUIRES MUCH MORE INFO ABOUT THE CASE, INCLUDING OTHER TREATMENTS THE PT WAS RECEIVING AT THE TIME, DIAGNOSIS, HISTORY, AND PAST CONDITIONS. THE INFO PROVIDED IN THE REPORT IS INSUFFICIENT TO DETERMINE IF THE REPORTED SYMPTOMS ARE ATTRIBUTABLE TO THE USE OF THE DEVICE. THE PT MAY HAVE HAD A CONDITION THAT WAS NOT APPROPRIATELY DIAGNOSED FOR WHICH THE DEVICE, OR OTHER ANTI-ANXIETY TREATMENTS, WAS NOT INDICATED.

    Description of Event or Problem · 1

    .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FISHER WALLACE STIMULATOR CES DEVICE JXK FISHER-WALLACE LABORATORIES LLC FW100 DEVICE NOT RETURNED

    Patients

    Seq Age Sex Outcome Treatment
    1 Other NO INFO AVAILABLE.