FDA.reportPublic FDA data

MAUDE MDR 2121091

MDR report key
2121091
Report number
MW5020946
Event key
0
Event type
3
Date of event
2011-04-24
Date received
2011-06-07
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DUPACOOPTI-GARD EYE PROTECTORDUPACO INC.HOY28310100414 N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-06-0701. O

Event Narratives#

D

Patient 1

A (B)(6) FEMALE PT'S EYEBROWS AND SKIN ADHERED TO OPTI-GARD EYE PROTECTOR DURING REMOVAL AFTER 4 HOUR SURGERY.