ANODYNE THERAPY
Received Nov 19, 2007 · Event occurred Aug 9, 2007
Report 1055581-2007-00019 · MDR key 951501
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
79 YR
- Burn, Thermal
- Treatment with medication(s)
Narrative
Additional Manufacturer Narrative
THE TREATING THERAPIST REPORTED TREATING THIS PT FOR 30 MINS AT AN ENERGY SETTING OF 10. THIS EXCEEDS THE RECOMMENDED GUIDELINES PROVIDED IN OUR IMPORTANT SAFETY INFORMATION AND INSTRUCTION MANUAL. THE UNIT INVOLVED IN THIS INCIDENT HAS BEEN RETURNED FOR EVALUATION, AND FOUND TO PERFORM 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 KIND.
Description of Event or Problem
PT IS REPORTED TO HAVE DEVELOPED A BURN, APPROX 1CM IN DIAMETER, ON HIS RIGHT CALF FOLLOWING TREATMENT WITH THE ANODYNE SYSTEM ADMINISTERED BY A HEALTH CARE PROFESSIONAL. THE PT WAS TREATED WITH ANTIBIOTICS, AND HAS HEALED.