BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRISMALIX

    MDR report key: 613950 · Received July 20, 2004

    Report

    Report Number
    9710053-2004-00002
    Event Type
    Other
    Date Received
    July 20, 2004
    Report Date
    June 25, 2004
    Manufacturer
    ALM S.A.
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PAINT CHIPPED OFF LIGHT AND FELL INTO PT WOUND AS OBSERVED BY OPERATING TEAM. MEDICAL FACILITY STAFF CLAIMS THE PAINT WAS REMOVED FROM THE PT WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRISMALIX SURGICAL LIGHT FSY ALM S.A. PRX 6400 ACS/DF/VZ *

    Patients

    Seq Age Sex Outcome Treatment
    1 *