ANODYNE THERAPY
Received Oct 27, 2008 · Event occurred Aug 1, 2003
Report 1055581-2008-00009 · MDR key 1214723
Device
Generic name
Intrared 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
Not reported
- Burn, Thermal
Narrative
Description of Event or Problem
PATIENT IS REPORTED TO HAVE DEVELOPED A BURN FOLLOWING TREATMENT WITH THE ANODYNE THERAPY PROFESSIONAL SYSTEM, APPLIED BY A HEALTH CARE PROFESSIONAL. INFORMATION IS NOT AVAILABLE AS TO THE SIZE AND LOCATION OF THE BURN, GENDER AND AGE OF THE PT, MEDICAL INTERVENTION RENDERED, OR HEALING DATE.
Additional Manufacturer Narrative
PATIENT IS REPORTED TO HAVE DEVELOPED A BURN FOLLOWING TREATMENT WITH THE ANODYNE THERAPY PROFESSIONAL SYSTEM FOR AT AN ENERGY SETTING OF 5. THIS IS WITHIN THE TREATMENT GUIDELINES PROVIDED IN THE IMPORTANT SAFETY AND INFO MANUAL. THE UNIT WAS RETURNED FOR EVAL, AND FOUND TO BE WITHIN OPERATING SPECIFICATIONS. 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. THIS ADVERSE EVENT IS BEING REPORTED AT THIS TIME AS A RESULT OF A CHANGE TO THE COMPANY DECISION TREE FOR REPORTABLE EVENTS.