BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEGA DYNE MEGA 2000

    MDR report key: 302208 · Received October 27, 2000

    Report

    Report Number
    MW1020268
    Event Type
    Injury
    Date Received
    October 27, 2000
    Date of Event
    May 29, 2000
    Report Date
    October 20, 2000
    Manufacturer
    MEGA DYNE MEDICAL PRODUCTS, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    PT ADMITTED FOR GASTRIC BYPASS. ON THE THIRD POST-OP DAY, A SKIN BREAKDOWN WAS NOTED BY STAFF BETWEEN SKIN FOLDS ON BACK. THE SURGEON FEELS THE SOURCE OF SKIN BREAKDOWN WAS CONTRIBUTED BY THE GROUNDING PAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEGA DYNE MEGA 2000 PATIENT RETURN ELECTRODE SYSTEM GEI MEGA DYNE MEDICAL PRODUCTS, INC. 00444048 *

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization