ANODYNE THERAPY
Received Oct 27, 2008 · Event occurred Aug 1, 2008
Report 1055581-2008-00012 · MDR key 1214729
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
Additional Manufacturer Narrative
PT IS REPORTED TO HAVE DEVELOPED A BURN FOLLOWING TREATMENT WITH THE ANODYNE THERAPY PROFESSIONAL SYSTEM 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 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 NATURE. THIS ADVERSE EVENT IS BEING REPORTED AT THIS TIME AS A RESULT OF A CHANGE TO THE COMPANY DECISION TREE FOR REPORTABLE EVENTS.
Description of Event or Problem
PT IS REPORTED TO HAVE DEVELOPED A BURN FOLLOWING TREATMENT WITH THE ANODYNE THERAPY PROFESSIONAL SYSTEM, APPLIED BY A HEALTH CARE PROFESSIONAL. INFO IS NOT AVAILABLE AS TO THE SIZE AND LOCATION OF THE BURN, GENDER AND AGE OF THE PT, MEDICAL INTERVENTION RENDERED, OR HEALING DATE.