BEUDAMED
    FDA Adverse Event Other Summary report: N

    LASE

    MDR report key: 258936 · Received January 13, 2000

    Report

    Report Number
    2183911-2000-00001
    Event Type
    Other
    Date Received
    January 13, 2000
    Date of Event
    June 30, 1997
    Report Date
    January 10, 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 BECAME AWARE OF A CLAIMED INJURY BY LEGAL SUMMONS. RECEIVED SHORTLY THEREAFTER. THE EVENT OCCURRED ON 6/30/1997. A PRODUCT COMPLAINT WAS NOT MADE BY THE PHYSICIAN, INSTITUTION, SALES PERSON OR ANYONE ELSE CONCERNING THE USE OF THE PRODUCT OR MALFUNCTION. THE PRODUCT WAS NOT RETURNED. NO DEVICE FAILURE WAS REPORTED. NO INJURY WAS REPORTED TO CLARUS OTHER THAN THE LEGAL SUMMONS REFERRED TO ABOVE. CLARUS MEDICAL DOES NOT HAVE ANY KNOWLEDGE OF A DEFECTIVE DEVICE FOR THIS EVENT. THIS WAS A CUSTOM DEVICE REQUESTED BY THE PHYSICIAN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other