BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 2202672 · Received August 8, 2011

    Report

    Report Number
    1518293-2011-00130
    Event Type
    Malfunction
    Date Received
    August 8, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 12, 2011
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    KQS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 THEY WERE PERFORMING A UROLOGY PROCEDURE WHEN THE SYSTEM FLUORO FAILED. STAFF BROUGHT IN A PORTABLE C-ARM FLUORO UNIT AND PHYSICIAN COMPLETED THE PROCEDURE WITHOUT FURTHER INCIDENT. CUSTOMER REFUSED TO PROVIDE PATIENT OR PROCEDURAL INFORMATION OTHER THAN TO SAY THE PROCEDURE WAS COMPLETED AND PATIENT 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