BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 528272 · Received May 19, 2004

    Report

    Report Number
    MW1032113
    Event Type
    Malfunction
    Date Received
    May 19, 2004
    Date of Event
    May 3, 2004
    Report Date
    May 10, 2004
    Manufacturer
    RADIATION PRODUCTS DESIGN, INC.
    Product Code
    HOY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2004 THE EYSHIELD WAS SOAKING IN A SOLUTION OF SALINE. WHEN THE PT ARRIVED FOR TREATMENT THE EYE SHIELD WAS TAKEN OUT OF THE SOLUTION AND PUT INTO THE PT'S EYE, AT THE TIME THE THERAPIST WAS ATTACHING A CORD TO THE EYE SHIELD FOR EASIER HANDLING AND NOTICED THAT A BLACK FILM WAS GETTING ON THE GLOVES. EXAMINING THE SHIELD THE THERAPISTS DISCOVERED A SPOT OF THE SILVER LINING HAD COME OFF AND SEEMED ROUGH TO THE TOUCH - IT WAS BROUGHT TO THE DOCTOR'S AND DOSIMETRIST'S ATTENTION AND WAS EXCHANGED FOR ANOTHER ONE. THE PT HAD AN OPHTHALMOLOGIST APPOINTMENT AND WAS TOLD THEY HAD A SCRATCHED CORNEA. THEY WERE ON BREAK FOR 1 WEEK. WHEN THEY RETURNED 2004 THE THERAPIST WERE GETTING SET UP FOR THEM WHILE THEY WERE BEING RE-EVALUATED BY THE DOCTOR. THE DOCTOR DECIDED TO CONTINUE THEM ON BREAK. THE THERAPIST WENT TO CLEAN-UP THE SET UP AND NOTICED THIS EYESHIELD ALSO HAD A SPOT OF SILVER MISSING. THIS SPOT OF SILVER LINING WAS THERE BEFORE THEY PUT IT INTO THE SOLUTION. REPORTER CALLED RADIATION PRODUCTS DESIGN, INC. AND THEY ASKED THEM TO SEND BACK THE EYESHIELDS AND THEY WOULD REPLACE THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * SILVER PLATED EYE SHIELDS HOY RADIATION PRODUCTS DESIGN, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR