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MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-05-19 for * manufactured by Radiation Products Design, Inc..

Event Text Entries

[319968] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1032113
• MDR Report Key: 528272
• Date Received: 2004-05-19
• Date of Report: 2004-05-10
• Date of Event: 2004-05-03
• Date Added to Maude: 2004-06-08
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: *
• Generic Name: SILVER PLATED EYE SHIELDS
• Product Code: HOY
• Date Received: 2004-05-19
• Returned To Mfg: 2004-05-10
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 517460
• Manufacturer: RADIATION PRODUCTS DESIGN, INC.
• Manufacturer Address: 5218 BARTHEL IND ALBERTVILLE MN 55301 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2004-05-19