BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILLUMENA PEDESTAL, BASE ASSY

    MDR report key: 2770340 · Received October 1, 2012

    Report

    Report Number
    1518293-2012-00183
    Event Type
    Injury
    Date Received
    October 1, 2012
    Date of Event
    September 12, 2012
    Report Date
    October 1, 2012
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    DXT
    PMA / PMN Number
    K963071
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PENDING INVESTIGATION. UPON RECEIPT OF INVESTIGATION, A MEDWATCH 3500A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON (B)(6), THE CUSTOMER REPORTS THAT THE INJECTOR DIDN'T SHOW ANY MESSAGE ABOUT "AIR IN SYRINGE" AND DID NOT STOP, CUSTOMER VIEWED THE AIR BUBBLE ON THE DISPLAY OF THE X-RAY SYSTEM AFTER. CUSTOMER REPORTS THE AIR BUBBLE WAS NOT BIG SO MUCH TO CREATE AN INCIDENT SO THEY DO NOT RELEASE ANY OTHER INFO ABOUT THE PT AND THE TREATMENT. CUSTOMER USE 800101 EMPTY SYRINGE (LOT NUMBER UNK). CONTRAST MEDIA UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ILLUMENA PEDESTAL, BASE ASSY DXT LIEBEL-FLARSHEIM CO. ILLUMENA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other HANDIFIL (LOT# UNK)| COVIDIEN 150ML SYRINGE: (B)(4)