BEUDAMED
    FDA Adverse Event Other Summary report: N

    STRATUS OCT

    MDR report key: 688841 · Received March 13, 2006

    Report

    Report Number
    2918630-2006-00001
    Event Type
    Other
    Date Received
    March 13, 2006
    Date of Event
    February 14, 2006
    Report Date
    March 9, 2006
    Manufacturer
    CARL ZEISS MEDITEC, INC.
    Product Code
    HLI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERWENT ROUTINE EYE EXAMINATIONS FOR GLAUCOMA, INCLUDING STRATUS OCT IMAGING. WHILE UNDERGOING THE PROCEDURE,THE PATIENT COMPLAINED OF BEING BOTHERED BY THE BRIGHT LIGHT EMITTED BY THE INSTRUMENT DURING SCANNING. SHORTLY THEREAFTER , PATIENT HAD AN EPISODE OF SEIZURE DESCRIBED AS DISORIENTATION, UNRESPONSIVENESS, AND MUSCLE CONTRACTIONS WITHOUT TONGUE BITING AND INCONTINENCE LASTING APPROXIMATELY 45 SECONDS. UPON EXAMINATION BY A PARAMEDIC, PATIENT WAS TAKEN TO AN EMERGENCY ROOM FOR FURTHER CARE. NO UNTOWARD SEQUELAE WERE NOTED AFTER THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATUS OCT OPTICAL COHERENCE TOMOGRAPHY SCANNER HLI CARL ZEISS MEDITEC, INC. 3000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other