BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCERTO

    MDR report key: 3042910 · Received April 4, 2013

    Report

    Report Number
    3003288808-2013-00149
    Event Type
    Malfunction
    Date Received
    April 4, 2013
    Report Date
    March 8, 2013
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM A FACILITY REPORTING SECONDARY ENERGY TOO HIGH MESSAGE WAS DISPLAYED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139165 CONCERTO OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990602 NA

    Patients

    Seq Age Sex Outcome Treatment
    1