ANODYNE THERAPY
Received Oct 27, 2008 · Event occurred Aug 22, 2005
Report 1055581-2008-00011 · MDR key 1214730
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 BUTTOCKS FOLLOWING TREATMENT WITH THE ANODYNE THERAPY PROFESSIONAL SYSTEM. PATIENT DID NOT RECEIVE MEDICAL INTERVENTION AND HAS HEALED.
Additional Manufacturer Narrative
PATIENT IS REPORTED TO HAVE DEVELOPED A BURN ON HER BUTTOCKS FOLLOWING TREATMENT WITH THE ANODYNE THERAPY PROFESSIONAL SYSTEM FOR 30 MINUTES AT AN ENERGY SETTING OF 6. FACILITY REPORTED THAT THE PT LAID ON THE THERAPY PADS WHICH IS CLEARLY STATED AS A PRECAUTION IN THE IMPORTANT SAFETY AND INSTRUCTION MANUAL. THE UNIT INVOLVED IN THIS INCIDENT WAS RETURNED FOR EVALUATION AND FOUND TO BE OPERATING WITHIN 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 TYPE. THIS ADVERSE EVENT IS BEING REPORTED AT THIS TIME, AS A RESULT OF A CHANGE TO THE COMPANY DECISION TREE FOR REPORTABLE EVENTS.