BEUDAMED
    FDA Adverse Event Other Summary report: N

    LASER

    MDR report key: 807780 · Received January 17, 2007

    Report

    Report Number
    2183911-2007-00001
    Event Type
    Other
    Date Received
    January 17, 2007
    Date of Event
    July 28, 2003
    Report Date
    January 17, 2007
    Manufacturer
    CLARUS MEDICAL, LLC.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PROBLEM WITH THE DEVICE OR PROCEDURE WERE REPORTED BY THE SALES REP. OR ATTENDING PHYSICIAN. CLARUS MEDICAL FIRST AWARE OF POTENTIAL PT INJURY WHEN NOTIFIED OF A LAWSUIT BY AN INDEPENDENT SALES REP ON 01/15/2007. NO DEVICE HAS BEEN RETURNED FOR EVALUATION. NO DEVICE WAS EVALUATED SINCE ALL OF THE INFO WE HAVE INDICATES, THIS WAS NOT A DEVICE PROBLEM.

    Description of Event or Problem · 1

    CLARUS MEDICAL WAS NOTIFIED ON 01/15/2007 BY AN INDEPENDENT SALES REP LISTED BELOW AS THE INITIAL REPORTED THAT THERE IS A CURRENT LAWSUIT FOLLOWING THE LAST LASE (LASER DISCECTOMY) CASE DONE BY THE DR. THE PT CLAIMS A SUBSEQUENT LOSS OF MOTOR FUNCTION FOLLOWING THE PROCEDURE. THE INFO PROVIDED BY THE SALES REP STAFF PRESENT DURING THE PROCEDURE WAS, "THE CASE WENT WELL, WITH NO INDICATIONS OF ANY PROBLEMS HE KNEW OF." CLARUS MEDICAL WAS FIRST AWARE OF THIS POTENTIAL ADVERSE EVENT ON 01/15/2007 WHEN CONTACTED BY THE SALE REP REGARDING A LAWSUIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LASER LASER DISCECTOMY DEVICE GEX CLARUS MEDICAL, LLC. NI *

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other