BEUDAMED
    FDA Adverse Event Summary report: N

    CLARUS LASE

    MDR report key: 448199 · Received March 11, 2003

    Report

    Report Number
    2183911-2003-00001
    Date Received
    March 11, 2003
    Date of Event
    February 14, 2003
    Report Date
    March 7, 2003
    Manufacturer
    CLARUS MEDICAL, LLC.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN THAT AFTER A DISCECTOMY PROCEDURE THE PATIENT REPORTED BI-LATERAL FOOT DROP AND DYSESTHESIA. THE PATIENT IS BEING TREATED BY A PHYSICIAN FOR THESE PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLARUS LASE LASER ASSISED SPINAL DISCECTOMY GEX CLARUS MEDICAL, LLC. 1100-010 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Disability