FDA.reportPublic FDA data

MAUDE MDR 528272

MDR report key
528272
Report number
MW1032113
Event key
0
Event type
3
Date of event
2004-05-03
Date received
2004-05-19
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1*SILVER PLATED EYE SHIELDSRADIATION PRODUCTS DESIGN, INC.HOY***NR

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12004-05-190

Event Narratives#

D

Patient 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.