BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERA 1.5T MASTER/NOVA

    MDR report key: 1872661 · Received September 29, 2010

    Report

    Report Number
    3003768277-2010-00207
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    September 12, 2010
    Report Date
    September 17, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    LNH
    PMA / PMN Number
    K001796
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (METHOD, RESULTS, CONCLUSIONS) - THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SENT TO THE FDA. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT HAS AN MR EXAM. THE PATIENT WAS SCANNED IN THE HEAD FIRST POSITION WITH THE QUADRATURE BODY COIL (QBC). NO RF COILS USED. A FEW DAYS AFTER THE EXAMINATION, THE PATIENT CALLED THE HOSPITAL TO REPORT TWO 2ND DEGREE BLISTERS WITH A SIZE OF APPROX 4 CM ON THE INNER THIGHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERA 1.5T MASTER/NOVA LNH (MAGNETIC RESONANCE DIAGNOSTIC DEVICE) LNH PHILIPS MEDICAL SYSTEMS 781106 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Other