ANODYNE
Received Jul 30, 2007 · Event occurred Jul 26, 2007
Report MW5003212 · MDR key 888575
Device
Generic name
Infrared Light
Product problems
- Unknown (for use when the device problem is not known)
Patient
56 YR
- Blister(s)
- Pain
- Skin Discoloration
- Burning Sensation
- Discomfort
- Burn, Thermal
Narrative
Description of Event or Problem
DURING A PHYSICAL THERAPY TREATMENT, AN ANODYNE INFRARED LIGHT UNIT WAS USED ON MY FEET AND LEGS, FOR 30 MINUTES. MY LEG STARTED BURNING BEFORE THE 30 MIN TIME FRAME. I REPORTED IT TO THE THERAPIST, WHO MOVED THE UNIT TO A DIFFERENT SPOT. BECAUSE I WAS STILL EXPERIENCING BURNING ON THE INSIDE OF MY RIGHT CALF, THE UNIT WAS REMOVED. THE RESULT WAS AN AREA APPROX. 5X4 INCHES OF REDNESS, AND A BLISTERS THAT IS 2 1/2 X 2 INCHES -PLUS SMALLER BLISTERS BELOW THE LARGE ONE-. SIGNIFICANT PAIN AND DISCOMFORT FOLLOWED FOR DAYS, INCLUDING DEEP ACHING AND SHARP RADIATING PAIN, BOTH ABOVE AND BELOW THE BURN SITE. THE INJURY IS CURRENT AND HAS NOT HEALED. DATES OF USE: 2007, APPROX 20 MIN. DIAGNOSIS OR REASON FOR USE: PLANTER FASCIITIS. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED? YES.