BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 1396814 · Received March 11, 2009

    Report

    Report Number
    1518293-2009-00053
    Event Type
    Malfunction
    Date Received
    March 11, 2009
    Date of Event
    February 10, 2009
    Report Date
    February 10, 2009
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    KQS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON 02/24/09 - CUSTOMER REPORTS DURING A RETROGRADE CYSTOGRAM ON A (B) (6) FEMALE, THE FLUORO STOPPED WORKING. THEY WERE ABLE TO COMPLETE THE PROCEDURE, AND THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUT EXT DR FINAL ASSY-REVERSE UROLOGY SUITES KQS LIEBEL-FLARSHEIM CO. HUT EXT DR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR