FDA.reportPublic FDA data

MAUDE MDR 1174063

MDR report key
1174063
Report number
MW5008396
Event key
0
Event type
3
Date received
2008-09-25
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
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
1GLAUCOMA LASER SCANHKXN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12008-09-250

Event Narratives#

D

Patient 1

PT WAS PUT ON THE LASER SCAN AND DEVELOPED THE FOLLOWING SYMPTOMS! BURNED EYES, BLUE CIRCLE AND BLISTERS ON BOTH EYES, SHE INITIALLY GOT CLOUDY VISION AND IS NOW HAVING PAIN AND PRESSURE ON HER EYES, AND HER EYES ARE IRRITATED. PT STATED THAT THE REASON SHE INITIALLY WENT TO DOCTOR WAS HIGH BLOOD PRESSURE, BUT THEY PUT HER ON THIS SCAN EQUIPMENT. PT HAD NO DEVICE ID INFO AVAILABLE.