BEUDAMED
    FDA Adverse Event Other Summary report: N

    HRW WRIST COIL

    MDR report key: 621065 · Received July 13, 2005

    Report

    Report Number
    2183553-2005-00011
    Event Type
    Other
    Date Received
    July 13, 2005
    Date of Event
    June 15, 2005
    Report Date
    July 13, 2005
    Manufacturer
    GE MEDICAL SYSTEMS
    Product Code
    LNH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MRI SCAN USING A WRIST COIL, A PATIENT FELT A WARMING SENSATION ON THE WRIST. THE PATIENT CALLED THE NEXT DAY TO REPORT BLISTERING ON THE INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HRW WRIST COIL MAGNETIC RESONANCE LNH GE MEDICAL SYSTEMS 100809 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other