BEUDAMED
    FDA Adverse Event Other Summary report: N

    IOTRODE PH STANDARD SIZE

    MDR report key: 274907 · Received April 20, 2000

    Report

    Report Number
    1626179-2000-00003
    Event Type
    Other
    Date Received
    April 20, 2000
    Report Date
    April 20, 2000
    Manufacturer
    HENLEY HEALTHCARE, INC.
    Product Code
    EGJ
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MFR RECEIVED A COMPLAINT THAT AN IOTRODE PH PAD LEFT A BLACK BURN ON A PT. THE BURN WAS REPORTED TO BE CIGARETTE SIZE AND TOOK APPROXIMATELY 2 WEEKS TO HEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IOTRODE PH STANDARD SIZE IONTOPHORESIS PAIN MANAGEMENT SYSTEM EGJ HENLEY HEALTHCARE, INC. IOTRODE PH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other