TUNGSTEN * 936-596

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-03-29 for TUNGSTEN * 936-596 manufactured by Radiation Product Design, Inc..

Event Text Entries

[18274805] Patient with mycosis fungoides lymphoma and right eye ectropian, had bilateral tungsten 3mm shields placed in his eyes to protect his eyes from radiation treatment. Tobradex ointment was placed in both shields prior to insertion in the eyes. The patient sustained a right eye corneal abrasion (left eye was fine). After the fact, the staff examined the shield and noted that the shield to the right eye might not have been smooth. They were able to feel, but not see a nick in the shield. What was the original intended procedure? Radiation to eye lids. Device #1is this a laboratory device or laboratory test? No.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	3052062
MDR Report Key	3052062
Date Received	2013-03-29
Date of Report	2013-03-28
Date of Event	2013-03-14
Report Date	2013-03-28
Date Reported to FDA	2013-03-29
Date Reported to Mfgr	2013-04-11
Date Added to Maude	2013-04-11
Event Key	0
Report Source Code	User Facility report
Manufacturer Link	N
Number of Patients in Event	0
Adverse Event Flag	3
Product Problem Flag	3
Reprocessed and Reused Flag	0
Reporter Occupation	RISK MANAGER
Health Professional	3
Initial Report to FDA	3
Report to FDA	3
Event Location	3
Single Use	0
Previous Use Code	0
Event Type	3
Type of Report	3

Device Details

Brand Name	TUNGSTEN
Generic Name	SHIELD, EYE, RADIOLOGICAL
Product Code	IWS
Date Received	2013-03-29
Model Number	*
Catalog Number	936-596
Lot Number	*
ID Number	*
Device Availability	Y
Device Age	4.5 YR
Device Sequence No	1
Device Event Key	0
Manufacturer	RADIATION PRODUCT DESIGN, INC.
Manufacturer Address	5218 BARTHEL INDUSTRIAL DRIVE ALBERTVILLE MN 55301 US 55301

Patients

Patient Number	Treatment	Outcome	Date
1	0		2013-03-29