MalfunctionILY
ANODYNE THERAPY, LLC
Received Apr 25, 2008 · Event occurred Aug 28, 2007
Report MW5006451 · MDR key 1035283
Device
Product problems
- Unknown (for use when the device problem is not known)
Patient
Not reported
- Skin Discoloration
- Skin Tears
- Therapy/non-surgical treatment, additional
- Burn, Thermal
Narrative
Description of Event or Problem
PATIENT TREATED WITH ANODYNE INFRARED PHOTO. TREATMENT PROTOCOL FOLLOWED WITH INSPECTION OF THE SKIN AREA TO BE TREATED. THE NEXT DAY, PATIENT CAME TO THE PT DEPARTMENT AND STATED, THAT HE HAD A BURN ON HIS SKIN WHERE THE TREATMENT WAS GIVEN. THE AREA SHOWED A SKIN TEAR AND A RED AREA MEASURING 4 X 2.5 CM. THE AREA WAS INSPECTED AND TREATED BY THE WOUND CARE NURSE. PATIENT INSTRUCTIONS GIVEN.