InjuryILY
VECTRA GENISYS LASER
Received Jun 19, 2009 · Event occurred May 16, 2009
Report 1022819-2009-00155 · MDR key 1406217
Device
Product problems
- Unknown (for use when the device problem is not known)
Patient
32 YR
- Burning Sensation
Narrative
Description of Event or Problem
PATIENT FELT BURNING SENSATION DURING LASER TREATMENT FOR LOWER BACK PAIN. NO VISIBLE MARKS. PATIENT DID NOT REQUIRE ADDITIONAL MEDICAL ATTENTION.
Additional Manufacturer Narrative
A DEVICE EVALUATION WAS PERFORMED BY OUR ENGINEERING DEPARTMENT. ROOT CAUSE IS UNKNOWN BECAUSE THE DEVICE PERFORMED TO SPECIFICATION AND TO ITS INTENDED USE. THE ENGINEERING DEPARTMENT DID NOT FIND ANY PROBLEMS WITH THE DEVICE.