ANODYNE THERAPY
Received Dec 4, 2007 · Event occurred Nov 3, 2007
Report 1055581-2007-00022 · MDR key 959788
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
77 YR
- Burn(s)
- Improved patient condition
- Treatment with medication(s)
Narrative
Description of Event or Problem
PATIENT IS REPORTED TO HAVE DEVELOPED A BURN ON HER CALVES FOLLOWING TREATMENT WITH THE ANODYNE THERAPY SYSTEM WHICH WAS ADMINISTERED BY A HEALTH CARE PROFESSIONAL. THE PATIENT WAS TREATED WITH SILVADENE, AND IS HEALING.
Additional Manufacturer Narrative
THERAPIST REPORTED TREATING THIS PATIENT FOR 30 MINUTES AT AN ENERGY SETTING OF 9, WHICH EXCEEDS THE GUIDELINES PROVIDED IN OUR IMPORTANT SAFETY INFORMATION AND INSTRUCTION MANUAL. THE UNIT INVOLVED IN THIS INCIDENT HAS BEEN RETURNED FOR EVALUATION, AND FOUND TO BE OUT OF OPERATING SPECIFICATIONS, BUT THESE FINDINGS WOULD NOT HAVE CAUSED THIS 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 OR UNITS IN DISTRIBUTION. COMPANY CONTINUES TO MONITOR AND TREND EVENTS OF THIS KIND.