BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GROUNDING PLATE A1200

    MDR report key: 25306452 · Received May 27, 2026

    Report

    Report Number
    3002750084-2026-00051
    Event Type
    Injury
    Date Received
    May 27, 2026
    Report Date
    May 27, 2026
    Manufacturer
    ASPEN SURGICAL PRODUCTS, INC.
    Product Code
    GEI
    UDI-DI
    00887482176948
    PMA / PMN Number
    K021817
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS IN PROCESS OF BEING RETURNED FOR EVALUATION, AND THE INVESTIGATION IS ONGOING. ONCE WE HAVE ADDITIONAL RELEVANT INFORMATION IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGES "WE PURCHASED A BRAND NEW BOVIE FOR MFI MEDICAL. THE GROUNDING PLATE HAD CAUSED A BURN IN ONE PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89124 GROUNDING PLATE A1200 GROUNDING PLATE GEI ASPEN SURGICAL PRODUCTS, INC. A1204P UNKNOWN 00887482176948

    Patients

    Seq Age Sex Outcome Treatment
    1