BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVELIGHT EX500 ECIMER LASER

    MDR report key: 2841984 · Received November 14, 2012

    Report

    Report Number
    3003288808-2012-00481
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    October 15, 2012
    Report Date
    October 15, 2012
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008/P0
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    NURSE

    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 INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT SOME OF THE NURSES HAVE NOTICED THE SMELL OF FLUORINE IN THE LASER ROOM. NO PTS OR SURGEONS HAVE NOTICED THE ODOR. AFTER WORKING IN THE LASER ROOM ALL DAY, SOME OF THE NURSES HAVE NOT FELT WELL, AND ONE OF THEM HAS FELT THE GAS ON HER TONGUE. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WAVELIGHT EX500 ECIMER LASER OPHTHALMIC ECIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990713 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other