BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDLINE

    MDR report key: 25045260 · Received April 30, 2026

    Report

    Report Number
    1417592-2026-00706
    Event Type
    Injury
    Date Received
    April 30, 2026
    Date of Event
    March 9, 2026
    Report Date
    April 30, 2026
    Manufacturer
    MEDLINE INDUSTRIES LP
    Product Code
    GEI
    UDI-DI
    10193489082531
    PMA / PMN Number
    K212093
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTD THAT, DURING GENDER AFFIRMING BILATERAL MASTECTOMY WITH FREE NIPPLE GRAFT, "THERE WERE 2 UNITS IN USE" AND "EACH UNIT HAD A NON-MEDTRONIC PEN PLUGGED INTO THE MONOPOLAR PORT. UNIT ALSO HAD A NON-MEDTRONIC REM PAD PLUGGED INTO THE REM PAD PORT THE NON-MEDTRONIC REM PAD WAS PLACED ON THE PATIENT'S UPPER THIGH." "THE MONOPOLAR SETTINGS WERE SET TO 60/60." "THE PATIENT SUDDENLY STARTED TO BRADY DOWN WHILE USING BOTH HAND PIECES." "THE PATIENT ENDED UP IN ASYSTOLE AND CHEST COMPRESSIONS HAD TO BE PERFORMED." IT WAS REPORTED, THAT "ROSC (RETURN OF SPONTANEOUS CIRCULATION) WAS ACHIEVED, AND THE PATIENT WAS BROUGHT TO THE PACU (POST-ANESTHESIA CARE UNIT) EXTUBATED." "THE SURGICAL TIME AND HOSPITALIZATION WERE EXTENDED, AND THE PATIENT IS NOW IN THE ICU.". IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTED TO SERIOUS INJURY, THEREFORE, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    "THE PATIENT SUDDENLY STARTED TO BRADY DOWN WHILE USING BOTH HANDPIECES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1102875 MEDLINE PAD, GROUNDING, UNIVERSAL, SPLIT, 9' GEI MEDLINE INDUSTRIES LP 10193489082531

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other