BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATUS OCT PATIENT MODEL D

    MDR report key: 1210867 · Received October 22, 2008

    Report

    Report Number
    MW5008724
    Event Type
    Injury
    Date Received
    October 22, 2008
    Date of Event
    August 20, 2008
    Report Date
    October 22, 2008
    Manufacturer
    CARL ZEISS MEDITEC.
    Product Code
    HLI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT CONTACTED THE OFFICE 7 DAYS AFTER THE USE OF THE OCT EQUIPMENT ON HER, COMPLAINING OF "BURNING IN HER EYES" AND "BLISTERING".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATUS OCT PATIENT MODEL D OCT HLI CARL ZEISS MEDITEC. 3000

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR