BEUDAMED
    FDA Adverse Event Other Summary report: N

    EXACT ACCEL

    MDR report key: 591639 · Received April 15, 2005

    Report

    Report Number
    1034973-2005-00002
    Event Type
    Other
    Date Received
    April 15, 2005
    Date of Event
    March 9, 2005
    Report Date
    March 17, 2005
    Manufacturer
    CTI PET SYSTEMS, INC.
    Product Code
    KPS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT CLAIMS THE POSITIONING LASERS ON THE PET SCANNER BURNT CORNEAS. PATIENT OPENED HER EYES BRIEFLY WHILE BEING POSITIONED AND SAW A RED LIGHT. OPHTHALMOLOGIST GAVE PATIENT A PRESCRIPTION FOR EYE DROPS TO BE USED FOR ONE WEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXACT ACCEL PET SCANNER KPS CTI PET SYSTEMS, INC. 3600211-00 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other