BEUDAMED
    FDA Adverse Event Other Summary report: N

    LASE

    MDR report key: 258943 · Received January 13, 2000

    Report

    Report Number
    2183911-2000-00002
    Event Type
    Other
    Date Received
    January 13, 2000
    Date of Event
    June 9, 1997
    Report Date
    January 11, 2000
    Manufacturer
    CLARUS MEDICAL SYSTEMS, INC.
    Product Code
    GEX
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CLARUS MEDICAL HAS LEARNED THROUGH LEGAL ACTION THAT A PT MAY HAVE BEEN INJURED DURING A LASE PROCEDURE ON 6/9/1997. CO HAS REASON TO BELIEVE THAT THE PHYSICIAN USED A STANDARD CLARUS MEDICAL LASE DEVICE TO PERFORM A CERVICAL DISC DECOMPRESSION. DIRECTIONS FOR USE FOR THIS DEVICE REFERS TO LUMBAR USE ONLY. NO DEVICE FAILURE OR INJURY WAS REPORTED TO CLARUS BY THE PHYSICIAN OR INSTITUTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other