ANODYNE THERAPY
Received Oct 27, 2008
Report 1055581-2008-00007 · MDR key 1214724
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
- Improved patient condition
- Burn, Thermal
Narrative
Description of Event or Problem
PATIENT IS REPORTED TO HAVE DEVELOPED A BURN ON THE BACK OF THE HAND FOLLOWING TREATMENT WITH THE ANODYNE THERAPY PROFESSIONAL SYSTEM. THERE IS NO RECORD AS TO THE DATE OF THIS EVENT, BUT IT WAS REPORTED IN EARLY 2005. THERE IS NO INFO ON FILE CONCERNING THE AGE OR GENDER OF THE PT, SIZE OF THE BURN OR MEDICAL INTERVENTION RENDERED. PATIENT HAS HEALED.
Additional Manufacturer Narrative
PATIENT IS REPORTED TO HAVE DEVELOPED A BURN ON THE BACK OF THE HAND FOLLOWING TREATMENT WITH THE ANODYNE THERAPY PROFESSIONAL SYSTEM AT AN ENERGY SETTING OF 7. 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 WITHIN TEMPERATURE SPECIFICATIONS. A BROKEN WIRE WAS IDENTIFIED, BUT WOULD NOT HAVE CAUSED THIS EVENT. 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.