BEUDAMED
    FDA Adverse Event Other Summary report: N

    LASER KIT DEVICE

    MDR report key: 551277 · Received April 19, 2004

    Report

    Report Number
    2183911-2004-00002
    Event Type
    Other
    Date Received
    April 19, 2004
    Date of Event
    April 11, 2004
    Report Date
    April 16, 2004
    Manufacturer
    CLARUS MEDICAL, LLC.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    MFR REC'D A SUMMONS IN REGARDS TO THIS MATTER. ALL THAT IS KNOWN IS THE DATE OF THE EVENT AND A CLAIM OF INJURY TO THE PT, BY THE PT. PLACE OF EVENT, PHYSICIAN AND TYPE(MODEL), SERIAL NUMBER OF DEVICE CLAIMED TO CAUSE THE INJURY ARE ALL UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LASER KIT DEVICE LASER ASSISTED ENDOSCOPIC SPINAL DISECTOMY GEX CLARUS MEDICAL, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other