BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALLURA XPER FD20

    MDR report key: 1150343 · Received August 21, 2008

    Report

    Report Number
    1217116-2008-00061
    Event Type
    Other
    Date Received
    August 21, 2008
    Date of Event
    April 1, 2008
    Report Date
    July 22, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    IZI
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS WAS REPORTED TO MFR VIA MEDWATCH FORM. THE PROBLEM STAES, PHYSICIAN INSERTED 5 STENTS, RECORDED FLUOROSCOPY TIME OF 67.5 MINUTES. DISCHARGED HOME TWO DAYS LATER. APPROX TWO WEEKS AFTER IMPLANT OF STENTS, PT RETURNED TO EMERGENCY ROOM COMPLAINING OF CHEST PAIN. AS PLANNED, ONE MONTH AFTER INITIAL IMPLANT, PHYSICIAN INSERTED ANOTHER STENT, RECORDED FLUOROSCOPY TIME OF 107 MINUTES. DISCHARGED HOME THE NEXT DAY. NINE DAYS AFTER SECOND IMPLANT, PT DISCOVERED A RED AREA ON HIS BACK BETWEEN THE SHOULDER BLADES THAT LOOKED LIKE SUNBURN. IT MEASURED 3 INCHES BY 3 INCHES. THE AREA GOT PROGRESSIVELY WORSE. THE AREA LOOKED MORE INFLAMED. PT WENT TO A DERMATOLOGIST APPROX 3 WEEKS AFTER DISCOVERY. DERMATOLOGIST EXAMINED THE AREA AND TOOK A BIOPSY SAMPLE. THE DERMATOLOGIST SAID IT LOOKED LIKE A RADIATION BURN. PATHOLOGIST REPORTED A DIFFERENTIAL DIAGNOSIS INCLUDING A FIXED DRUERUPTION, ERYTHEMA MULTIFORMA, OF AN AUTOIMMUNE CONNECTIVE DISEASE; SUBACUTE RADIATION DERMATITIS ALSO IN THE DIFFERENTIAL DIAGNOSIS, DERMATOLOGIST PUT PT ON TOPICORT CREAM. DEVICE WAS INSPECTED BY A THIRD PARTY. THE X-RAY EQUIPMENT WAS FOUND TO SUBSTANTIALLY COMPLY WITH STATE AND FEDERAL REGULATIONS AS WELL AS NATIONAL PERFORMANCE STANDARDS ESTABLISHED FOR GOOD RADIOLOGICAL COMPLIANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLURA XPER FD20 IZI (ANGIOGRAPHIC X-RAY SYSTEM) IZI PHILIPS MEDICAL SYSTEMS 722006 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other