ANODYNE THERAPY
Received Nov 21, 2007 · Event occurred Oct 17, 2007
Report 1055581-2007-00021 · MDR key 952643
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
77 YR
- Burn(s)
- Treatment with medication(s)
Narrative
Additional Manufacturer Narrative
FACILITY REPORTED THEY TREATED THIS PATIENT FOR 45 MINUTES AT AN ENERGY SETTING OF 10 WHICH EXCEEDS THE TREATMENT GUIDELINES PROVIDED IN OUR IMPORTANT SAFETY INFORMATION AND INSTRUCTION MANUAL. THE PATIENT HAD RECEIVED 30-40 PRIOR TREATMENTS WITH THIS UNIT WITHOUT INCIDENT. THE UNIT INVOLVED IN THIS INCIDENT HAS BEEN RETURNED FOR EVALUATION AND FOUND TO PERFORM TO 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 NATURE.
Description of Event or Problem
PATIENT IS REPORTED TO HAVE DEVELOPED A BURN ON HER RIGHT SCAPULA FOLLOWING TREATMENT WITH THE ANODYNE THERAPY SYSTEM WHICH WAS ADMINISTERED BY A HEALTH CARE PROFESSIONAL. THE PATIENT HAS BEEN TREATED WITH SILVADENE, AND IS HEALING.