BEUDAMED
    FDA Adverse Event Other Summary report: N

    QDR BONE DENSITOMETER

    MDR report key: 1073970 · Received July 1, 2008

    Report

    Report Number
    1221300-2008-00005
    Event Type
    Other
    Date Received
    July 1, 2008
    Date of Event
    May 23, 2008
    Report Date
    July 1, 2008
    Manufacturer
    HOLOGIC, INC.
    Product Code
    KGI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DESIGN SPEC FOR THE LASER WAS REVIEWED - IT WAS DETERMINED THAT THE LASER NEVER MOVES OVER PT'S HEAD. IT IS A POSITIONING LASER AND SHUTS OFF AUTOMATICALLY AFTER 30 SECONDS. THIS WAS CONFIRMED BY FIELD SERVICE ENGINEER. THE LASER IS CLASS II, BUT RECENT TESTING BY AN INDEPENDENT LAB INDICATED THAT THE LASER RATHER THAN CLASS II FALLS INTO CATEGORY I LASER, WHICH IS THE SAFEST LASER, AND THERE SHOULD BE NO POSSIBILITY OF THE REPORTED INJURY. BASED ON ALL AVAILABLE INFO AND THE TESTING OF THE DEVICE, OUR CONCLUSION IS THAT THE DEVICE PERFORMS IN ACCORDANCE WITH THE SPEC AND WE CANNOT CONFIRM THAT THE INJURY REPORTED BY THE PT WAS RELATED TO OUR DEVICE.

    Description of Event or Problem · 1

    CUSTOMER E-MAIL HOLOGIC AND REPORTED THE FOLLOWING: ONE OF THEIR PT REPORTED THAT SHE STARED AT A POSITIONING LASER LIGHT FOR APPROX 1 1/2 MINS, AND ONLY THEN SHE NOTICED THE WARNING SIGN THAT SAID NOT TO STARE INTO THE LIGHT. THE PT SAID THAT HER EYES HAVE BEEN HURTING/BOTHERING HER SINCE THAT TIME, SO SHE WENT TO THE EYE DOCTOR. DOCTOR TOLD HER THAT SHE HAD BLEEDING BEHIND HER EYES AND THAT IT COULD HAVE BEEN CAUSED BY LASER LIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QDR BONE DENSITOMETER BONE DENSITOMETER KGI HOLOGIC, INC. QDR 4500 SL

    Patients

    Seq Age Sex Outcome Treatment
    1