BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GAIT MYOELECTRIC STIMULATION II

    MDR report key: 3757037 · Received April 11, 2014

    Report

    Report Number
    MW5035665
    Event Type
    Injury
    Date Received
    April 11, 2014
    Date of Event
    January 16, 2014
    Report Date
    March 5, 2014
    Manufacturer
    *
    Product Code
    MKD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE MOTHER OF THIS PT WITH CEREBRAL PALSY CALLED TO REPORT A SKIN IRRITATION ON THE SUPERIOR EDGE OF THE PLANTAR FLEXOR PAD OF THE WATER BASED STIMULATION ELECTRODE. THE CHILD HAD BEEN RECEIVING ELECTRICAL STIMULATION TO IMPROVE HER WALKING FOR 6 WEEKS PRIOR TO THIS EVENT. THE FAMILY BROUGHT THE CHILD TO THE CLINIC ON (B)(6) 2014 AND THE SKIN SHOWED A HORIZONTAL ABRASION WITH SMALL SCABS WERE THE SKIN HAD BEGUN TO HEAL DURING THE PREVIOUS 4 DAYS. THE PADS WERE REMOVED AND STIMULATION WAS DISCONTINUED. THE PRINCIPAL INVESTIGATOR PHOTOGRAPHED THE SKIN ABRASION TO DOCUMENT THE SKIN BREAKDOWN. INVESTIGATOR NOTIFIED THE (B)(4) OF THIS EVENT. THE (B)(4) COMMITTEE DETERMINED THE CHILD SHOULD BE REMOVED FROM THE STUDY. THE STUDY WAS SUSPENDED DUE TO A TOTAL OF 4 CHILDREN WHO DEVELOPED A SIMILAR SKIN IRRITATION. THE SKIN BEGAN TO HEAL WHEN THE PADS WERE REMOVED AND THE STIMULATION WAS DISCONTINUED. WITHIN A 9 DAYS, THE SCABS HEALED AND RETURNED TO A HEALTHY PINK COLOR. THE SKIN HEALED AND REDNESS RESOLVED WITHIN 6 WEEKS. DATES OF USE: (B)(6) 2013 TO (B)(6) 2014. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220444 GAIT MYOELECTRIC STIMULATION II GMES II MKD * GMES II *

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR