inforMED
MalfunctionHOY

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Received May 19, 2004 · Event occurred May 3, 2004

Report MW1032113 · MDR key 528272

Device

Generic name

Silver Plated Eye Shields

Model number

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Catalog number

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Lot number

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Product problems

  • Detachment Of Device Component

Patient

82 YR

  • Corneal Abrasion

Narrative

Description of Event or Problem

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.