FDA Adverse Event Other Summary report: N

GLAUCOMA LASER SCAN

MDR report key: 1174063 · Received September 25, 2008

Report

Report Number
MW5008396
Event Type
Other
Date Received
September 25, 2008
Report Date
September 25, 2008
Product Code
HKX
Report Source
Voluntary report
Reporter Location
FL, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 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.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 GLAUCOMA LASER SCAN HKX

Patients

Seq Age Sex Outcome Treatment
1 39 YR