BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEGRETTO WAVE

    MDR report key: 2161042 · Received June 17, 2011

    Report

    Report Number
    3003288808-2011-00188
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Report Date
    May 20, 2011
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008/P02
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ATTORNEY REPRESENTING THIRD PARTY SERVICE ENGINEER ALLEGES GAS SUPPLIED UNDER MAINTENANCE CONTRACT DAMAGED LASER. SPECIFIC DAMAGE HAS NOT BEEN DEFINED. NO PATIENT INVOLVEMENT WAS REPORTED, NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEGRETTO WAVE OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990600 NA

    Patients

    Seq Age Sex Outcome Treatment
    1