BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RHYTHMLINK®

    MDR report key: 24002646 · Received January 8, 2026

    Report

    Report Number
    24002646
    Event Type
    Malfunction
    Date Received
    January 8, 2026
    Date of Event
    December 15, 2025
    Report Date
    December 22, 2025
    Manufacturer
    RHYTHMLINK INTERNATIONAL, LLC
    Product Code
    GXY
    UDI-DI
    10816312023654
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    FROM STAFF: PT SEEN AT BEDSIDE IN SKIN RESPONSE FOR EVALUATION OF SUSPECTED PRESSURE INJURY TO FOREHEAD (TOP). INJURY DUE TO EEG [(ELECTROENCEPHALOGRAM)] LEAD. INJURY WAS FOUND AFTER EGG REMOVAL TODAY. WOUND APPEARS AS SHALLOW TISSUE LOSS WITH PINK WOUND BASE. EDGES ARE DEFINED AND IN THE SHAPE OF EEG LEAD. THIS INJURY IS CLASSIFIED AS A STAGE 2 PRESSURE INJURY DUE TO MECHANICAL DEVICE. RECOMMEND LEAVING AREA OTA [OPEN TO AIR] AND CONTINUE TO MONITOR AREA. WOUND TEAM WILL CONTINUE TO FOLLOW PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62829 RHYTHMLINK® ELECTRODE, CUTANEOUS GXY RHYTHMLINK INTERNATIONAL, LLC DC2415 10816312023654

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Male Other