BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 1250819 · Received December 2, 2008

    Report

    Report Number
    1518293-2008-00360
    Event Type
    Malfunction
    Date Received
    December 2, 2008
    Date of Event
    November 3, 2008
    Report Date
    November 3, 2008
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    KQS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON 11/10: CUSTOMER REPORTS PT UNDERGOING A URETEROSCOPY FOR STENT PLACEMENT WHEN THE FLUORO FAILED. CUSTOMER DOES NOT RECALL ANY PT PROCEDURAL DETAILS, BUT STATES THE PROCEDURE WAS COMPLETED WITH NO INJURIES TO BE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK