BEUDAMED
    FDA Adverse Event Other Summary report: N

    TOSHIBA

    MDR report key: 1661537 · Received April 12, 2010

    Report

    Report Number
    2020563-2010-00006
    Event Type
    Other
    Date Received
    April 12, 2010
    Date of Event
    March 4, 2010
    Report Date
    March 26, 2010
    Manufacturer
    TOSHIBA MEDICAL SYSTEMS CORPORATION
    Product Code
    MOS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MRI TECHNOLOGIST SCANNED THE PATIENT AND DID NOT ISOLATE THE BICEP AREA FROM THE COIL CABLE. DURING THE SCAN, THE PATIENT RANG THE CALL BELL TO REPORT THAT HIS BICEP WAS HURTING. THE TECHNOLOGIST PLACED THE PATIENT'S ARM ABOVE HIS HEAD AND FINISHED THE STUDY WITH NO ADDITIONAL INCIDENT. AFTER THE SCAN WAS COMPLETED, THE PATIENT COMPLAINED ABOUT HIS BICEP AREA. IT WAS RED AND TENDER AND WAS ADVISED NOT TO PUT ICE ON IT. THE TOSHIBA CUSTOMER ENGINEER CONFIRMED THAT THE COIL WAS WORKING PROPERLY. THE PATIENT HAS NOT RETURNED AND IS BEING CONTACTED FOR AN UPDATE OF HIS CONDITION.

    Description of Event or Problem · 1

    DURING AN MRI EXAMINATION, THE PATIENT'S BICEP BECAME RED AND TENDER ALLEGEDLY DUE TO BICEP TOUCHING THE CABLE OF THE TORSO COIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOSHIBA COIL, QD TORSO SPEEDER ARRAY MOS TOSHIBA MEDICAL SYSTEMS CORPORATION MJAB-137A/S1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other