BEUDAMED
    FDA Adverse Event Other Summary report: N

    STRATUSOCT

    MDR report key: 585450 · Received March 18, 2005

    Report

    Report Number
    2918630-2005-00002
    Event Type
    Other
    Date Received
    March 18, 2005
    Date of Event
    March 2, 2005
    Report Date
    March 18, 2005
    Manufacturer
    CARL ZEISS MEDITEC INC
    Product Code
    HLI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    A PATIENT EXPERIENCED AN ELECTROSTATIC DISCHARGE WHLE TAKING AN EXAM. THE DISCHARGE OCCURRED IN THE VICINITY OF THE PATIENT'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 * Other