BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 1922564 · Received November 19, 2010

    Report

    Report Number
    1518293-2010-00157
    Event Type
    Malfunction
    Date Received
    November 19, 2010
    Date of Event
    November 2, 2010
    Report Date
    November 2, 2010
    Manufacturer
    LIEBEL-FLARSHEIM CO
    Product Code
    KQS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    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): CUSTOMER REPORTS FLUORO FAILED DURING PT PROCEDURE. CUSTOMER PROVIDED NO PT OR PROCEDURAL INFORMATION OTHER THAN TO SAY PROCEDURE WAS COMPLETED AND PT IS FINE.

    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