ANODYNE THERAPY
Received Oct 27, 2008 · Event occurred Jun 21, 2005
Report 1055581-2008-00005 · MDR key 1214719
Device
Generic name
Infrared Lamp
Manufacturer
Anodyne Therapy, LlcModel number
480Catalog number
UNK
Lot number
NA
Product problems
- Unknown (for use when the device problem is not known)
Patient
75 YR
- Improved patient condition
- Burn, Thermal
Narrative
Description of Event or Problem
PT IS REPORTED TO HAVE DEVELOPED A BURN ON THE TOP OF HIS FOOT FOLLOWING TREATMENT WITH THE ANODYNE THERAPY PROFESSIONAL SYSTEM, APPLIED BY A HEALTH CARE PROFESSIONAL. THE PT DID NOT RECEIVE MEDICAL INTERVENTION AND HAS HEALED.
Additional Manufacturer Narrative
UNIT WAS NOT RETURNED FOR EVAL. THE TREATING FACILITY REPORTS TREATING THIS PT FOR THE FOURTH TIME AND AT AN ENERGY SETTING OF 8 FOR 30 TO 45 MINUTES DURATION. THIS IS WITHIN THE TREATMENT GUIDELINES PROVIDED IN THE IMPORTANT SAFETY AND INFO MANUAL. THE FACILITY REPORTED THIS EVENT FIVE MONTHS AFTER IT OCCURED, AND THEY CONFIRMED THAT IN THESE FIVE MONTHS, THEY HAVE HAD NO OTHER ADVERSE EVENTS OCCUR WITH THIS UNIT. 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. THIS ADVERSE EVENT IS BEING REPORTED AT THIS TIME AS A RESULT OF A CHANGE TO THE COMPANY DECISION TREE FOR REPORTABLE EVENTS.