BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEGA SOFT REUSABLE PATIENT RETURN ELECTRODE

    MDR report key: 18747981 · Received February 21, 2024

    Report

    Report Number
    18747981
    Event Type
    Injury
    Date Received
    February 21, 2024
    Date of Event
    January 2, 2024
    Report Date
    January 5, 2024
    Manufacturer
    MEGADYNE MEDICAL PRODUCTS
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    YOUNG CHILD HAVING ADENOIDECTOMY SURGERY. OPERATIVE TABLE CONSISTED OF GELLI-ROLL HEATING PAD WITH MEGADYNE PATIENT RETURN ELECTRODE PAD ATOP AND THEN A SAHARA SUPER-ABSORBENT OPERATING ROOM (OR) TABLE SHEET, IMPERVIOUS, ON TOP OF THAT WITH WHITE, CLOTH SIDE TO PATIENT. PATIENT THEN HAD A DRAW SHEET UNDER HIM, ABOVE THE OR TABLE SHEET. FOLLOWING THE 11 MINUTE SURGERY, HE WAS BROUGHT TO THE PEDIATRIC OUTPATIENT SURGERY AREA TO RECOVER, HOWEVER, THE REGISTERED NURSE (RN) NOTICED A BURN TO THE PATIENT'S RIGHT BUTTOCK. PATIENT HAS BEEN REFERRED TO A BURN CENTER FOR EVALUATION AND TREATMENT. HE MAY NEED PLASTIC SURGERY IN HIS FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47899 MEGA SOFT REUSABLE PATIENT RETURN ELECTRODE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEGADYNE MEDICAL PRODUCTS 0845

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Male Other| R| H