BEUDAMED
    FDA Adverse Event Other Summary report: N

    LASE MODEL 1100-002

    MDR report key: 336714 · Received May 18, 2001

    Report

    Report Number
    2183911-2001-00001
    Event Type
    Other
    Date Received
    May 18, 2001
    Date of Event
    May 17, 2001
    Report Date
    May 18, 2001
    Manufacturer
    CLARUS MEDICAL, LLC.
    Product Code
    GEX
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE USER REPORTED AN INJURY TO CLARUS MEDICAL AT THE TIME OF FOLLOW-UP TO THIS RETURNED PRODUCT. THE PRODUCT WAS RECEIVED IN 2001. THE INITIAL REPORT FROM THE SALES REP. INDICATED "THERE WAS NO INJURY. EVERYONE WAS WEARING GLASSES (LASER)". WHEN THE CLINIC WAS CALLED BY CLARUS MEDICAL ON 5/18/01 THE CLINIC SAID THAT THE DOCTOR USING THE DEVICE WAS INJURED BY THE LASER ENERGY. THE LASER FIBER BROKE AND BURNT THROUGH DOCTOR'S GOWN AND CAUSED A QUARTER SIZED RED MARK ON DOCTOR'S ARM. CLARUS MEDICAL WAS TOLD THAT CLINIC MADE A REPORT BEFORE RETURNING PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23857 LASE MODEL 1100-002 ENDOSCOPIC DISCECTONY DEVICE GEX CLARUS MEDICAL, LLC. 1100-002 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA