BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS / ACHIEVA 1.5

    MDR report key: 1220907 · Received October 31, 2008

    Report

    Report Number
    MW5008868
    Event Type
    Injury
    Date Received
    October 31, 2008
    Date of Event
    October 17, 2008
    Report Date
    October 31, 2008
    Product Code
    LNH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    BURNED DURING AN MRI OF MY HIPS AND GROIN AREA. RESULTED IN COOKING SENSATION AND PHYSICAL BURNING SENSATION TO MY LEFT ARM DURING THE PROCEDURE. MUCH PAIN AND DISCOMFORT AFTERWARD INCLUDING THE DISCOLORING OF MY PENIS AND SCROTUM TO A DARK GRAY COLOR. MY GENERAL FEELING WAS THAT I HAD BEEN SUNBURNED AND THAT MY TESTES WERE IN A VISE. THE MRI WAS A PHILIPS ACHEIVA 1.5 -TAKEN FROM THE REPORT- I FEEL THE MACHINE WASN'T WORKING CORRECTLY AND/OR THE OPERATOR WASN'T DOING HIS JOB CORRECTLY. DURING THE PROCEDURE, MY HIPS WERE COVERED WITH A THICK HEAVY MATERIAL WITH TWO LARGE HOLES CUT IN IT THAT LINED UP GENERALLY WITH THE INSIDES OF MY HIPS. MY FEET WERE TIED TOGETHER AND A WEDGE OF SOME TYPE WAS PLACED BETWEEN MY LEGS JUST UNDER MY SCROTUM. PRODUCT NAME: PHILIPS ACHIEVA 1.5 MRI MACHINE OPERATOR OF THIS MACHINE: ORTHOPAEDIC SPECIALISTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILIPS / ACHIEVA 1.5 MRI LNH

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other