BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRO-ADJUSTER, ACCUWAVE, SMART ADJUSTER -SA201-

    MDR report key: 1366575 · Received April 17, 2009

    Report

    Report Number
    MW5010825
    Event Type
    Injury
    Date Received
    April 17, 2009
    Date of Event
    March 23, 2009
    Report Date
    April 17, 2009
    Product Code
    LXM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A DEVICE MADE BY SIGMA INSTRUMENTS WHICH IS MARKETED UNDER THE BRAND NAMES OF PRO-ADJUSTER, SPINELINER AND YP-412 IS USED BY CHIROPRACTORS TO MAKE ADJUSTMENT ON THE SPINE AND THE NECK. THE DEVICE IS POORLY DESIGNED AND POORLY MANUFACTURED AND AFTER I WAS ADJUSTED WITH THIS DEVICE, I HAD DIFFICULTY HEARING. I HAVE SINCE FOUND OUT THAT THE DEVICE HAS BEEN TESTED AND THE "IMPULSE HEAD" WHICH COMES INTO CONTACT WITH THE PATIENT'S BODY HAS A MEASURED NOISE OUTPUT OF 95DB. I HAVE ALSO LEARNED THAT A NOISE LEVEL THAT HIGH CAN CAUSE PERMANENT HEARING LOSS. THIS COMPANY ADVERTISES THAT IT HAS MORE THAN 5,000 MACHINES OPERATING IN DOCTOR'S OFFICES AND THIS PRODUCT IS NOT SAFE AND CAN CAUSE PERMANENT HEARING LOSS. I WAS ALSO TOUCHED BY THE "IMPULSE HEAD' DURING THE DOCTOR'S EXAMINATION AND I RECEIVED A BURNING "HEAT" PAIN BECAUSE THE IMPULSE HEAD GETS SO HOT. I FOUND THIS INFORMATION ABOUT THE MANUFACTURER: DEVICE NAME: PRO ADJUSTER.ACUWAVE.S.M.A.R.T.ADJUSTER. TYPE: ADJUSTING OR JOINT MOBILIZATION INSTRUMENT MANIPULATOR.PLUNGER-LIKE JOINT DEVICE CODE: LXM CATEGORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRO-ADJUSTER, ACCUWAVE, SMART ADJUSTER -SA201- PRO-ADJUSTER LXM PRO-ADJUSTER

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention| S