ANODYNE THERAPY
Received Oct 27, 2008 · Event occurred Oct 28, 2008
Report 1055581-2008-00010 · MDR key 1214721
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
Not reported
- Burn, Thermal
Narrative
Description of Event or Problem
PATIENT IS REPORTED TO HAVE DEVELOPED A BURN ON THE TOP OF THE LEFT FOOT, 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 TOP OF THE LEFT FOOT, FOLLOWING TREATMENT WITH THE ANODYNE THERAPY PROFESSIONAL SYSTEM FOR MORE THAN 30 MINUTES, AT AN ENERGY SETTING OF 10, AND THAT THEY BELIEVE A LOTION WAS APPLIED UNDER THE ARRAY. THESE PARAMETERS ARE NOT 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.