BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMREX MS-322

    MDR report key: 2240787 · Received September 5, 2011

    Report

    Report Number
    MW5022134
    Event Type
    Injury
    Date Received
    September 5, 2011
    Date of Event
    December 20, 2010
    Report Date
    September 5, 2011
    Manufacturer
    MED ELECTRONICS DYNATRONICS
    Product Code
    IPF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    DURING A ROUTINE VISIT ON (B)(6), 2010 FOR TREATMENT OF LOWER BACK PAIN AND TO RELAX FATIGUED MUSCLES, ELECTRICAL STIMULATION AND ULTRASOUND TREATMENT WAS APPLIED BY (B)(6) OF QUAIL VALLEY CHIROPRACTIC RESULTING IN A SERIOUS INJURY WITH FIRST AND SECOND DEGREE BURNS OVER A VERY LARGE AREA OF MY BACKSIDE. THIS TREATMENT RESULTED IN BURNS, BLISTERING OF THE SKIN, AND SEVERE PAIN THAT LASTED MORE THEN A WEEK REQUIRING IMMEDIATE MEDICAL INTERVENTION AND ANTIBIOTIC TREATMENT FOR BURNS/BLISTERS AND LONG TERM DERMATOLOGICAL TREATMENT FOR SCARRING AND PIGMENTATION SKIN DISCOLORATION. AT THE TIME OF TREATMENT, I FELT A PULSATING, TINGLING SENSATION. EQUIPMENT USED IN TREATMENT INCLUDE AMR EX MODEL MS322/DYNATRONICS, SIGMA SPRAY ELECTRODE SOLUTION BY PARKER LABORATORIES, INC. AND DYNATRONICS MODEL DYNATRON 125 BY ULTRASOUND GEL SCRIPT HESSCO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMREX MS-322 MUSCLE STIMULATOR IPF MED ELECTRONICS DYNATRONICS MS-322 *
    2 DYNATRONIS DYNATRON MUSCLE STIMULATOR IMI DYNATRONICS DYNATRON 125
    3 SIGMA ELECTRODE SOLUTION GYB PARKER LABORATORIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 * Disability