BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIEMENS 1.5 TESLA ESPREE WITH DEDICATED EXTREMITY COIL

    MDR report key: 2175207 · Received July 19, 2011

    Report

    Report Number
    MW5021447
    Event Type
    Injury
    Date Received
    July 19, 2011
    Date of Event
    July 16, 2011
    Report Date
    July 19, 2011
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS, U.S.A.
    Product Code
    MRI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT MRI OF THE RIGHT KNEE WITHOUT CONTRAST. REPORTEDLY, DURING THE SCAN, THE PT COMPLAINED OF PAIN IN HER CALVES. UPON COMPLETION OF THE STUDY, THE PT COMPLAINED OF A BURNING FEELING. THE PT'S SKIN WAS INSPECTED WHILE SHE WAS STILL IN THE DEPARTMENT AND TWO DIME SIZED SUPERFICIAL CIRCLES WERE IDENTIFIED ON THE CALF. THE PT REPORTED HOURS LATER THAT THE AREA HAD WORSENED. DATES OF USE: (B)(6) 2011. DIAGNOSIS OR REASON FOR USE: MRI STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIEMENS 1.5 TESLA ESPREE WITH DEDICATED EXTREMITY COIL MRI SIEMENS MEDICAL SOLUTIONS, U.S.A. TESLA ESPREE

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other