BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTHROSTIM INSTRUMENT

    MDR report key: 5778259 · Received July 6, 2016

    Report

    Report Number
    MW5063282
    Event Type
    Injury
    Date Received
    July 6, 2016
    Date of Event
    June 2, 2016
    Report Date
    June 27, 2016
    Manufacturer
    INNOVATIVE MACHINERY PACKAGING AND CONVERTING INC.
    Product Code
    LXM
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CHIROPRACTOR (B)(6) USED THIS ON MY NECK. IT FELT LIKE MY CERVICAL VERTEBRAE WERE BEING PUMMELED. IT STRIKES VERY HARD AND FAST AND MY NECK WAS HIT WITH SOLID, HARD PLASTIC. IT WAS WAY TOO MUCH FORCE ON MY CERVICAL VERTEBRAE. AFTERWARDS MY CONDITION WAS WORSE. CHIROPRACTOR (B)(6) CONDUCTS HIS BUSINESS FROM HIS PROPERTY IN A NORMAL, ISOLATED AREA AT (B)(6), OUTSIDE CITY LIMITS. THE INSTRUMENT IS MECHANICAL AND STRIKES REALLY HARD WITH A LOT OF FORCE. I DO NOT THINK CHIROPRACTORS SHOULD BE ALLOWED TO USE THIS. THEY ARE NOT MEDICAL DOCTORS. I HAVE CONTACTED THE (B)(6) COUNTY SHERIFF'S DEPARTMENT. THE REASON I CONTACTED LAW ENFORCEMENT REGARDING THIS INCIDENT IS BECAUSE I TOLD (B)(6) I DID NOT WANT THIS INSTRUMENT BEING USED ON ME. HE DID NOT EXPLAIN WHAT THE INSTRUMENT WAS OR WHERE HE WAS GOING TO USE IT. THE CERVICAL VERTEBRAE ARE NOT MEANT TO TAKE A LOT OF FORCE. I HAVE ONLY HEARD OF MEDICAL DOCTORS USING MECHANIZED EQUIPMENT TO TREAT THE CERVICAL VERTEBRAE - EQUIPMENT I ASSUME TO HAVE BEEN APPROVED BY THE FDA. I HAD NEVER HEARD OF THIS EQUIPMENT AND HE USED IT ON MY NECK WITH WAY TOO MUCH FORCE. I FEEL HE WAS TRYING TO INJURE ME. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425340 ARTHROSTIM INSTRUMENT ARTHROSTIM INSTRUMENT LXM INNOVATIVE MACHINERY PACKAGING AND CONVERTING INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Disability