BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASER

    MDR report key: 168695 · Received May 21, 1998

    Report

    Report Number
    2183911-1998-09001
    Event Type
    Injury
    Date Received
    May 21, 1998
    Report Date
    May 21, 1998
    Manufacturer
    CLARUS MEDICAL SYSTEMS, INC.
    Product Code
    GEX
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    CLARUS BECAME AWARE OF THE INJURY BY LEGAL SUMMONS. THE EVENT OCCURRED ON 6/30/1997. NO DEVICE FAILURE WAS REPORTED. NO INJURY WAS REPORTED. THE DEVICE USED WAS NOT RETURNED TO CLARUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LASER LASER DISCECTOMY ENDOSCOPE KIT GEX CLARUS MEDICAL SYSTEMS, INC. 1100 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 *