BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RS-LBL LOW BACK CONDUCTIVE GARMENT

    MDR report key: 1190183 · Received October 6, 2008

    Report

    Report Number
    MW5008544
    Event Type
    Injury
    Date Received
    October 6, 2008
    Date of Event
    March 29, 2008
    Report Date
    October 6, 2008
    Manufacturer
    RS MEDICAL
    Product Code
    GZJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    I WAS PRESCRIBED THE RSMEDICAL TENS UNIT -RS-LB LOW BACK CONDUCTIVE GARMENT- BY MY PAIN SPECIALIST. I USED THIS PRODUCT FOR APPROXIMATELY FOUR HOURS AND WHEN I REMOVED IT, I FELT A BURNING SENSATION IN MY BACK, SO I HAD MY BOYFRIEND TO LOOK AT MY BACK AND IT HAD BLISTERS WHERE ALL THE PADS WERE TOUCHING MY BACK. I SOUGHT MEDICAL ATTENTION FOR THIS AND WAS ADVISED TO SEE A DERMATOLOGIST. WHEN I WENT TO HIM UPON HIS EXAMINATION, I WAS TOLD THAT I HAD SEVERE BURNS ON MY BACK AND THAT IT WAS CAUSED BY THE CONDUCTIVE GARMENT. I HAVE BEEN ADVISED THAT I WILL NEED PLASTIC SURGERY TO GET RID OF THE SCARRING CAUSED BY THIS DEVICE. I HAVE CONTACTED FACILITY NUMEROUS TIMES AND NO ONE WILL RETURN MY CALLS CONCERNING THIS MATTER. I HAVE SPOKEN WITH AN ATTORNEY AND HAVE BEEN ADVISED THAT I NEED TO FILE THIS CLAIM FOR ALL MY DOCTORS EXPENSES AND MY PAIN AND SUFFERING. PLEASE CONTACT ME AS SOON AS POSSIBLE AND MAIL ME WITH THE INFORMATION ON WHAT I NEED TO DO NEXT. I AM PATIENTLY AWAITING TO HEAR FROM YOU. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: SEVERE BACK PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RS-LBL LOW BACK CONDUCTIVE GARMENT CONDUCTIVE GARMENT USED WITH THE RS-TENS PLUS DEVICE GZJ RS MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention RS-TENS PLUS UBIT| RD-LBL LOW BACK CONDUCTIVE GARMENT