BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-RAY MACHINE

    MDR report key: 11893440 · Received May 26, 2021

    Report

    Report Number
    MW5101585
    Event Type
    Malfunction
    Date Received
    May 26, 2021
    Date of Event
    March 10, 2021
    Report Date
    May 25, 2021
    Product Code
    IZF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I ATTENDED MY CHIROPRACTOR (B)(6) IN (B)(6) THIS MARCH AND THEY ASKED ME IF I WOULD GET AN X-RAY TO UPDATE MY 15 YEAR OLD RECORDS. I HESITANTLY CONSENTED BUT NOTICED SOMETHING STRANGE WHEN EVERY TIME THEY SHOT THE X-RAY AT MY EXPOSED TORSO I ACTUALLY FELT THE AIR VIBRATE AROUND ME. I DISTINCTLY REMEMBER THIS BECAUSE I HAVE NEVER FELT A PHYSICAL SENSATION FROM AN X-RAY BEFORE AND THIS SERIES MADE THE HAIR ON MY BODY TINGLE FOR A SHORT MOMENT EVERY SINGLE TIME THEY TOOK A SHOT. I FOUND THIS TROUBLING AND TRIED TO RESEARCH IF THIS WAS NORMAL. ACCORDING TO THE (B)(6) THIS SENSATION IS A SIGN OF A POTENTIALLY DANGEROUS MISUSE OF AN X-RAY DEVICE AND SHOULD BE REPORTED SOMEWHERE, SO I THOUGHT IT WOULD BE WORTH REPORTING IT TO YOU. PLEASE LET ME KNOW IF I SHOULD DO ANYTHING ABOUT THIS FOR MY OWN HEALTH. I THINK I IGNORED IT FOR A WHILE BECAUSE I HOPED IT WAS NORMAL BUT IT WAS VERY STRANGE AND THE MEMORY HAS STUCK WITH ME SINCE. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786878 X-RAY MACHINE SYSTEM, X-RAY, TOMOGRAPHIC IZF

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR