ANODYNE THERAPY
Received Sep 7, 2007 · Event occurred Jun 13, 2007
Report 1055581-2007-00015 · MDR key 908724
Device
Generic name
Infrared Lamp
Manufacturer
Anodyne Therapy, LlcModel number
480Catalog number
498005
Lot number
NA
Product problems
- Unknown (for use when the device problem is not known)
Patient
51 YR
- Improved patient condition
- Burn, Thermal
- Treatment with medication(s)
Narrative
Description of Event or Problem
PT IS REPORTED TO HAVE DEVELOPED A BURN ON HIS MEDIAL ANKLE, FOLLOWING TREATMENT WITH THE ANODYNE THERAPY PROFESSIONAL SYSTEM. PT WAS BEING TREATED BY A HEALTH CARE PROFESSIONAL FOR DIABETIC PERIPHERAL NEUROPATHY. PT WAS TREATED BY HIS DOCTOR WITH AN ANTIBIOTIC OINTMENT, AND HIS WOUND IS HEALING.
Additional Manufacturer Narrative
PT IS REPORTED TO HAVE DEVELOPED A BURN, APPROX 2 1/2" X 1 1/2" ON HIS MEDIAL ANKLE FOLLOWING TREATMENT WITH THE ANODYNE PROFESSIONAL SYSTEM. THE HEALTH CARE PROFESSIONAL ADMINISTERED TREATMENT FOR 30 MINUTES AT AN ENERGY SETTING OF 8. THIS IS WITHIN THE GUIDELINES PROVIDED IN THE IMPORTANT SAFETY INFO AND INSTRUCTIONS PROVIDED TO THE USER BY ANODYNE. THE UNIT INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION, AND DUTY CYCLE FAILURE WAS DETECTED. THE NUMBER OF INCIDENTS OF THIS TYPE REMAIN WELL WITHIN THE EXPECTED RATE FOR THIS PRODUCT BASED UPON THE NUMBER OF INCIDENTS REPORTED AND THE NUMBER OF UNITS IN DISTRIBUTION. COMPANY WILL CONTINUE TO MONITOR EVENTS OF THIS NATURE FOR TRENDING PURPOSES.