BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLURA XPER FD10

    MDR report key: 2885104 · Received December 19, 2012

    Report

    Report Number
    3003768277-2012-00088
    Event Type
    Injury
    Date Received
    December 19, 2012
    Date of Event
    September 13, 2012
    Report Date
    November 28, 2012
    Manufacturer
    PHILIPS HEALTHCARE - BET NETHERLANDS
    Product Code
    IZI
    PMA / PMN Number
    K031333
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AFTER A LONG PROCEDURE THE PATIENT SHOWED A LARGE RADIATION BURN TO THE TORSO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLURA XPER FD10 IZI, MQB IZI PHILIPS HEALTHCARE - BET NETHERLANDS 722003

    Patients

    Seq Age Sex Outcome Treatment
    1 Other