ANODYNE THERAPY
Received Oct 27, 2008 · Event occurred May 12, 2007
Report 1055581-2008-00015 · MDR key 1214720
Device
Generic name
Intrared Lamp
Manufacturer
Anodyne Therapy, LlcModel number
120Catalog number
498003
Lot number
NA
Product problems
- Unknown (for use when the device problem is not known)
Patient
54 YR
- Improved patient condition
- Burn, Thermal
Narrative
Description of Event or Problem
PATIENT IS REPORTED TO HAVE DEVELOPED A BURN ON THE BOTTOM ON HER FOOT FOLLOWING TREATMENT WITH THE ANODYNE THERAPY PROFESSIONAL SYSTEM. PATIENT DID NOT RECEIVE MEDICAL INTERVENTION AND HAS HEALED.
Additional Manufacturer Narrative
PATIENT REPORTED, DEVELOPING A BURN ON HER BOTTOM OF HER FOOT FOLLOWING TREATMENT WITH THE HOME UNIT. PATIENT REPORTED TREATING FOR 10 MINUTES ON ONE FOOT AND 20 MINUTES ON THE OTHER. 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 TYPE. THIS ADVERSE EVENT IS BEING REPORTED AT THIS TIME AS A RESULT OF A CHANGE TO THE COMPANY DECISION TREE FOR THE REPORTABLE EVENTS.