ANODYNE THERAPY
Received Oct 27, 2008
Report 1055581-2008-00008 · MDR key 1214722
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 ABOVE HIS ANKLE FOLLOWING TREATMENT WITH THE ANODYNE THERAPY PROFESSIONAL SYSTEM, APPLIED BY A HEALTH CARE PROFESSIONAL. NUMEROUS UNSUCCESSFUL ATTEMPTS WERE MADE TO DETERMINE INFO RELATIVE TO THE SIZE, DATE OF THE EVENT, AGE OF THE PT, AND DATE OF HEALING.
Additional Manufacturer Narrative
PATIENT IS REPORTED TO HAVE DEVELOPED A BURN ABOVE THE ANKLE FOLLOWING TREATMENT WITH THE ANODYNE THERAPY PROFESSIONAL SYSTEM FOR 30 MINUTES AT AN ENERGY SETTING OF 7. THIS IS WITHIN THE TREATMENT GUIDELINES PROVIDED IN THE IMPORTANT SAFETY AND INFORMATIONAL MANUAL. THE UNIT WAS RETURNED FOR EVAL, AND FOUND TO BE OPERATING WITHIN TEMPERATURE SPECIFICATIONS. A BROKEN BLACK WIRE WAS IDENTIFIED, BUT WOULD NOT HAVE CAUSED THE 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 THE NATURE. THIS ADVERSE EVENT IS BEING REPORTED AT THIS TIME AS A RESULT OF A CHANGE TO THE COMPANY DECISION TREE FOR REPORTABLE EVENTS.