BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROGUARD

    MDR report key: 24935949 · Received April 21, 2026

    Report

    Report Number
    9710376-2026-00003
    Event Type
    Injury
    Date Received
    April 21, 2026
    Date of Event
    March 24, 2026
    Report Date
    May 27, 2026
    Manufacturer
    TECHNOMED EUROPE
    Product Code
    GXZ
    UDI-DI
    08718375863213
    PMA / PMN Number
    K130136
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    TECHNOMED RECEIVED A COMPLAINT VIA MPOWER/CADWELL WITH A REPORTED INCIDENT THAT RESULTED IN A PATIENT BURN INVOLVING A NEUROGUARD ELECTRODE (REF#: S41-938; LOT#: 102884). THE NEUROGUARD ELECTRODE USED AND THE CADWELL EQUIPMENT WERE OWNED BY (B)(6). SMALL BURN NOTES AT ERBS POINT RECORDING SITE IN LEFT CLAVICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585567 NEUROGUARD DISPOSABLE SUBDERMAL NEEDLE ELECTRODE GXZ TECHNOMED EUROPE S41-938 102884 08718375863213

    Patients

    Seq Age Sex Outcome Treatment
    1