BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD10 C

    MDR report key: 4251097 · Received November 5, 2014

    Report

    Report Number
    3003768277-2014-00125
    Event Type
    Malfunction
    Date Received
    November 5, 2014
    Report Date
    October 7, 2014
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    IZI
    PMA / PMN Number
    K031333
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WHEN INVESTIGATION IS COMPLETED A FOLLOW UP REPORT WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    PHILIPS RECEIVED A COMPLAINT FROM A CUSTOMER THAT THE FLUOROSCOPY PEDAL WAS BENT SLIGHTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710442 ALLURA XPER FD10 C IZI PHILIPS HEALTHCARE 722001

    Patients

    Seq Age Sex Outcome Treatment
    1