ANODYNE THERAPY
Received Apr 23, 2008 · Event occurred Mar 18, 2008
Report 1055581-2008-00003 · MDR key 1034102
Device
Generic name
Infrared Lamp
Manufacturer
Anodyne Therapy, LlcModel number
480Catalog number
498006
Lot number
NA
Product problems
- Unknown (for use when the device problem is not known)
Patient
65 YR
- Burn, Thermal
- Treatment with medication(s)
Narrative
Description of Event or Problem
PT IS REPORTED TO HAVE DEVELOPED THREE FIRST DEGREE AND ONE SECOND DEGREE BURN ON HIS OUTER LEFT LEG MEASURING A TOTAL OF 2 1/2 CM X 1 1/2 FOLLOWING TREATMENT WITH THE ANODYNE PROFESSIONAL SYSTEM APPLIED BY A HEALTH CARE PROFESSIONAL. THE PT RECEIVED MEDICAL INTERVENTION OF SILVADENE AND A DRESSING AND IS HEALING.
Additional Manufacturer Narrative
THE TREATING FACILITY REPORTS TREATING THIS PT FOR THE FIRST TIME WITH ANODYNE THERAPY SYSTEM. THEY REPORT TREATING FOR 25 MINS AT AN ENERGY SETTING OF 9. THIS EXCEEDS THE RECOMMENDED TREATMENT GUIDELINES PROVIDED IN THE IMPORTANT SAFETY INFO AND INSTRUCTION MANUAL SUPPLIED WITH THE SYSTEM. THE NUMBER OF INCIDENTS OF THIS TYPE REMAIN WITHIN THE EXPECTED RATE FOR THIS PRODUCT BASED UPON THE NUMBER OF INCIDENTS REPORTED AND THE NUMBER OF UNITS IN DISTRIBUTION. COMPANY CONTINUES TO MONITOR AND TREND EVENTS OF THIS NATURE.