BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 2153495 · Received June 21, 2011

    Report

    Report Number
    1518293-2011-00111
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    May 27, 2011
    Report Date
    May 27, 2011
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    KQS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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): FACILITY BIOMED REPORTS THAT STAFF WERE PERFORMING AN UNDETERMINED UROLOGY PROCEDURE WHEN SYSTEM FAILED. STAFF MOVED PATIENT TO ANOTHER ROOM WHERE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. CUSTOMER PROVIDED NO PATIENT OR PROCEDURAL INFORMATION OTHER THAN TO SAY PROCEDURE WAS COMPLETED AND PATIENT IS FINE. NO REPORTED INJURY.

    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