ANODYNE THERAPY
Received Oct 27, 2008 · Event occurred Feb 22, 2006
Report 1055581-2008-00013 · MDR key 1214728
Device
Generic name
Intrared Lamp
Manufacturer
Anodyne Therapy, LlcModel number
120Catalog number
498003
Lot number
NA
Product problems
- Unknown (for use when the device problem is not known)
Patient
38 YR
- Improved patient condition
- Burn, Thermal
Narrative
Description of Event or Problem
PT IS REPORTED TO HAVE DEVELOPED A BURN ON THE BACK OF THE RIGHT HIP FOLLOWING THE TREATMENT WITH THE ANODYNE THERAPY HOME SYSTEM. THE PT DID NOT RECEIVE MEDICAL INTERVENTION AND HAS HEALED.
Additional Manufacturer Narrative
THE PT IS REPORTED TO HAVE DEVELOPED A BURN ON THE BACK OF HIS RIGHT HIP, FOLLOWING TREATMENT ON THE BUTTOCKS FOR 25 MINUTES. PT STATES HE WAS LYING ON ARRAYS, AND SO DID NOT FOLLOW THE TREATMENT GUIDELINES PROVIDED IN THE IMPORTANT SAFETY AND INSTRUCTION MANUAL. THE UNIT WAS RETURNED FOR EVAL, AND FOUND TO BE OPERATING WITHIN TEMPERATURE SPECIFICATIONS. VOLTAGE READINGS WERE DETECTED .17V BELOW SPECIFICATION, BUT THIS WOULD NOT HAVE CAUSED THIS ADVERSE EVENT. THE NUMBER OF INCIDENTS OF THIS TYPE REMAIN WITHIN THE EXPECTED RATE FOR THIS PRODUCT BASED UPON THE NUMBER OF INCIDENTS REPORTED AND NUMBER OF UNITS IN DISTRIBUTION. COMPANY CONTINUES TO MONITOR AND TREND EVENTS OF THIS TYPE. THIS ADVERSE EVENT IS BEING REPORTED AT THIS TIME AS A RESULT OF A CHANGE TO THE COMPANY DECISION TREE FOR THE REPORTABLE EVENTS.