BREEZE
Received Jan 19, 2009 · Event occurred Jan 14, 2009
Report MW5009710 · MDR key 1294023
Device
Generic name
Isee - 360
Product problems
- Unknown (for use when the device problem is not known)
Patient
52 YR
- Skin Discoloration
- Swelling
Narrative
Description of Event or Problem
I PURCHASED AN ISEE-360 EYE AND TEMPLE MASSAGER. AFTER THE THIRD USE, I WOKE UP TO MY EYES AND FACE SEVERELY SWOLLEN AND DISCOLORED. AFTER 5 DAYS, THE SWELLING IS STARTING TO GO AWAY. I USED THE MASSAGER AS DIRECTED. KNOWING THAT THIS WAS A HEAVY DUTY UNIT, I ONLY USED IT 5 MINUTES THE FIRST DAY, 10 THE SECOND AND 15 THE THIRD. I WANTED TO CONTACT THE MFR TO SEE WHAT THEY SUGGESTED. THERE IS NO CONTACT INFO ON THE BOX OR IN THE INSTRUCTIONS. THE ONLY WARNINGS TELL YOU NOT TO USE IT WHEN TALKING, DRIVING, OR BATHING. THERE ARE NO WARNINGS ABOUT ANY ADVERSE EFFECTS. I WAS ABLE TO FIND SOME CONTACT INFO ON THE INTERNET, AND CONTACTED THE US REP, WHO HAS PROMISED TO TALK TO THE CO WHO MANUFACTURES THIS AND RECOMMENDED, I FILE THIS REPORT.