MalfunctionILY
ANODYNE THERAPY PROFESSIONAL SYSTEM
Received Jul 23, 2013 · Event occurred Jul 15, 2013
Report MW5031075 · MDR key 3252332
Device
Generic name
Andoyne Infrared Light Therapy Device
Manufacturer
Anodyne Therapy ServicesModel number
480Lot number
CE#04-155555
Product problems
- Temperature Problem
Patient
74 YR
- Partial thickness (Second Degree) Burn
Narrative
Description of Event or Problem
A PT EXPERIENCED A QUARTER -SIZED, FIRST TO SEND DEGREE BURN ON HER RIGHT CALF DURING THERAPY ON THAT EXTREMITY WITH AN ANDOYNE INFRARED LIGHT THERAPY DEVICE. REASON FOR USE: TO INCREASE CIRCULATION OF THE RIGHT LOWER EXTREMITY. THE PT REPORTED THAT HER PRIMARY CARE PHYSICIAN DIAGNOSED THE QUARTER-SIZED RED MARK ON HER RIGHT CALF AS A 1ST TO 2ND DEGREE BURN, AND THAT A TOPICAL OINTMENT WAS PRESCRIBED.