BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOGRAPH MMR

    MDR report key: 4003114 · Received August 11, 2014

    Report

    Report Number
    2240869-2014-06205
    Event Type
    Injury
    Date Received
    August 11, 2014
    Date of Event
    July 23, 2014
    Report Date
    July 24, 2014
    Manufacturer
    SIEMENS HEALTHCARE
    Product Code
    OUO
    PMA / PMN Number
    K103429
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY. NO SYSTEM OR COIL MALFUNCTION HAS BEEN FOUND TO DATE. SIEMENS WILL CONTINUE FURTHER INVESTIGATION OF THE SYSTEM COILS TO DETERMINE ROOT CAUSE. A SUPPLEMENT REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO SIEMENS THAT WHILE PERFORMING AN MR PET EXAMINATION, A FEMALE SUBJECT WITH LARGE BREASTS COMPLAINED OF BURNS ON HER BREAST. IT WAS REPORTED THAT THE SPINE COIL, AS WELL AS TWO BODY MATRIX COILS, WERE USED DURING THE EXAMINATION. THE LEFT BREAST WAS OBSERVED TO BE WARM TO THE TOUCH, BUT NOT TENDER AND NO BLISTER WAS PRESENT. THE RIGHT BREAST WAS OBSERVED TO BE WARM TO THE TOUCH, TENDER TO PALPATION AND A SMALL BLISTER WAS PRESENT. THE SUBJECT WAS TREATED WITH TOPICAL OINTMENT. THE STUDY WAS APPROXIMATELY 2 HOURS IN LENGTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475630 BIOGRAPH MMR TOMO IMAGER WITH NUC. MAG. RES OUO SIEMENS HEALTHCARE 10433372

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR