BEUDAMED
    FDA Adverse Event Other Summary report: N

    SIEMENS 1.5T TXRX 15 CH KNEE

    MDR report key: 2280452 · Received October 5, 2011

    Report

    Report Number
    3007350713-2011-00001
    Event Type
    Other
    Date Received
    October 5, 2011
    Date of Event
    July 22, 2011
    Report Date
    October 3, 2011
    Manufacturer
    QUALITY ELECTRODYNAMICS
    Product Code
    MOS
    PMA / PMN Number
    K082636
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTENDED USE: THE 1.5T KNEE ARRAY COIL IS INTENDED MAGNETIC RESONANCE IMAGING OF THE KNEE AS DESCRIBED IN K082636. THE PATIENT REPORTED A FOREARM BURN AFTER THIS DEVICE WAS USED FOR A THUMB EXAMINATION.

    Description of Event or Problem · 1

    IN THE AFTERNOON OF FRIDAY (B)(6), THE PATIENT REPORTED A REDDENING ON HIS RIGHT FOREARM FOLLOWING HIS THUMB EXAMINATION USING THE SIEMENS 1.5T KNEE COIL ON (B)(6) AROUND (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIEMENS 1.5T TXRX 15 CH KNEE COIL, MAGNETIC RESONANCE, SPECIALTY MOS QUALITY ELECTRODYNAMICS Q7000016

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other