ANODYNE THERAPY
Received Aug 31, 2007 · Event occurred Aug 5, 2007
Report 1055581-2007-00013 · MDR key 906680
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
84 YR
- Therapy/non-surgical treatment, additional
- Burn, Thermal
- Treatment with medication(s)
Narrative
Additional Manufacturer Narrative
PT IS REPORTED TO HAVE DEVELOPED A BURN ON A THIN SKIN AREA AT THE SCAPULA AREA OF THE SHOULDER FOLLOWING TREATMENT FOR 15 MINUTES AT AN ENERGY SETTING OF 7. THIS TREATMENT TIME AND SETTING IS WITHIN THE GUIDELINES PROVIDED IN THE IMPORTANT SAFETY INSTRUCTIONS AND INFO. THE THERAPIST HAD TREATED THIS PT ONE TIME PRIOR WITHOUT INCIDENT. THIS UNIT WAS RETURNED FOR EVALUATION, AND THE ARRAY CORD WIRE WAS FOUND TO BE BROKEN, BUT WOULD NOT HAVE CAUSED THIS EVENT. 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 PURPOSE.
Description of Event or Problem
PT IS REPORTED TO HAVE DEVELOPED A BURN ON SCAPULA AREA OF THE LEFT SHOULDER. THE BURN IS REPORTED TO HAVE DEVELOPED FOLLOWING TREATMENT WITH THE ANODYNE THERAPY PROFESSIONAL SYSTEM WHICH WAS ADMINISTERED BY A HEALTH CARE PROFESSIONAL. THE NURSE AT THE TREATING FACILITY PRESCRIBED SILVADENE, AND PT IS HEALING.