BEUDAMED
    FDA Adverse Event Other Summary report: N

    HENLEY HEALTHCARE - JELTRODE

    MDR report key: 289313 · Received August 10, 2000

    Report

    Report Number
    1626179-2000-00004
    Event Type
    Other
    Date Received
    August 10, 2000
    Date of Event
    June 2, 2000
    Report Date
    August 9, 2000
    Manufacturer
    HENLEY HEALTHCARE, INC.
    Product Code
    JOS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DR PERFORMED ELECTRICAL STIM ON PT USING HENLEY HEALTHCARE JELTRODE ELECTRODES AND ANOTHER MANUFACTURER'S STIM UNIT. ONE ELECTRODE WAS PLACED ON THE HEEL, AND ONE ON THE CREASE BETWEEN FOOT AND SHIN. THE PT HAD A SKIN REACTION WHICH WAS DESCRIBED AS BLISTERING AND SMALL BULLOUS FORMATIONS WITH THE AFFECTED AREA SHOWING A PERFECT IMPRINT OF THE ELECTRODE. THE DR DESCRIBED THE REACTION AS "VIOLENT". PREDNISONE WAS ADMINISTERED TO RESOLVE THE PROBLEM. THE INITIAL COMPLAINT CAME IN AS A PHONE CALL FROM THE RN ON 6/15/00. THE SEVERITY OF THE INJURY WAS NOT FULLY UNDERSTOOD UNTIL RECEIPT OF THE 6/28 LETTER AND SUBSEQUENT PHONE CONVERSATIONS WITH THE DR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HENLEY HEALTHCARE - JELTRODE JELTRODE ELECTRODE JOS HENLEY HEALTHCARE, INC. JEL0042 EMC

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other (SEE B7.)| ORAL VICODIN.| ELECTRICAL STIM WAS POST SURGERY.