BEUDAMED
    FDA Adverse Event Other Summary report: N

    STRATUSOCT

    MDR report key: 615698 · Received June 3, 2005

    Report

    Report Number
    2918630-2005-00004
    Event Type
    Other
    Date Received
    June 3, 2005
    Date of Event
    April 5, 2005
    Report Date
    May 26, 2005
    Manufacturer
    CARL ZEISS MEDITEC INC
    Product Code
    HLI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Description of Event or Problem · 1

    A PATIENT EXPERIENCED AN ELECTROSTATIC DISCHARGE WHEN TOUCHING THE DEVICE PT MODULE. THE DISCHARGE OCCURRED IN THE VICINITY OF THE PT'S EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATUSOCT OPTICAL CORNEAL TOMOGRAPHY HLI CARL ZEISS MEDITEC INC 3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other