BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERA 1.5 POWER/PULSAR

    MDR report key: 2113591 · Received June 1, 2011

    Report

    Report Number
    3003768277-2011-00401
    Event Type
    Injury
    Date Received
    June 1, 2011
    Report Date
    May 18, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    LNH
    PMA / PMN Number
    K001796
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (EVAL METHOD, RESULT, CONCLUSION): THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED A F/U REPORT WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    A PT WAS SCANNED WITH THE SENSE BODY COIL IN 90 DEGREES ROTATED POSITION OVER THE PT'S UPPER BODY. THE CABLES OF THE UPPER AND LOWER COIL PART RAN DIAGONAL TO THE SIDE OF THE TABLE. THE LOWER CABLE TOUCHED THE BACK SIDE OF THE PT'S RIGHT LEG. TWO DAYS AFTER THE EXAMINATION A BLISTER OF 3-5 CM WAS OBSERVED ON THE BACKSIDE OF THIS LEG. ON THE FRONT SIDE OF THE SAME LEG A REDDENING OF SKIN WAS OBSERVED WHERE THE UPPER CABLE WAS POSITIONED. INVESTIGATION OF THE EVENT IS STILL ONGOING AND A FINAL REPORT WILL FOLLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERA 1.5 POWER/PULSAR LNH PHILIPS HEALTHCARE 781105

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other