BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRASTIM ELECTRODES

    MDR report key: 19428512 · Received May 29, 2024

    Report

    Report Number
    MW5155574
    Event Type
    Injury
    Date Received
    May 29, 2024
    Date of Event
    May 14, 2024
    Report Date
    May 23, 2024
    Manufacturer
    AXELGAARD MFG. CO., LTD.
    Product Code
    GXY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    (B)(6) 2024 UPON INSPECTION OF SKIN PRE MODALITY APPLICATION THERE WAS AN AREA OF DARKENED DISCOLORED SKIN AREA RIGHT SIDE UPPER LUMBAR AREA (POTENTIAL BLISTER/POTENTIAL ABRASION). THIS WAS NOTED PRIOR TO MODALITY USE THAT SESSION. OUT OF PRECAUTION THIS AREA WAS AVOIDED DURING PAD PLACEMENT AND HP/MH WAS NOT APPLIED. NO CONCERNS WERE NOTED FOLLOWING PAD REMOVAL. AT HIS NEXT VISIT/FOLLOW UP ON (B)(6) 2024 NOTED 4 CIRCULAR M&M SIZE BURN/BLISTERED AREAS TO LUMBAR SPINE. LOCATION OF THESE AREAS WERE CONSISTENT WITH PAD PLACEMENT ON (B)(6) SESSION. AT THE TIME OF MODALITY COMPLETION, NO CONCERNS WERE OBSERVED, AND WERE DOCUMENTED AS SUCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328748 ULTRASTIM ELECTRODES ELECTRODE, CUTANEOUS GXY AXELGAARD MFG. CO., LTD. UF2040 203318

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Male Other