BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATUS DISPOSABLE GROUND PLATE ELECTROD

    MDR report key: 14136962 · Received April 15, 2022

    Report

    Report Number
    MW5109076
    Event Type
    Injury
    Date Received
    April 15, 2022
    Date of Event
    March 23, 2022
    Report Date
    April 13, 2022
    Manufacturer
    NATUS MANUFACTURING LIMITED
    Product Code
    GXY
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WE USED A NATUS DISPOSABLE GROUND PLATE ELECTRODE DURING QSART STUDY WHICH CAUSED A SMALL BLISTER FIVE MILLIMETER BURN ON PATIENT FOREARM. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2717129 NATUS DISPOSABLE GROUND PLATE ELECTROD ELECTRODE, CUTANEOUS GXY NATUS MANUFACTURING LIMITED 019-400500

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male Other IONTO4 IONTOPHORETIC STIMULATOR