InjuryILY

ANODYNE THERAPY

Received Oct 27, 2008 · Event occurred Feb 22, 2006

Report 1055581-2008-00006 · MDR key 1214725

Device

Generic name

Infrared Lamp

Manufacturer

Anodyne Therapy, Llc

Model number

120

Catalog number

498003

Lot number

Product problems

Unknown (for use when the device problem is not known)

Patient

51 YR

Improved patient condition
Burn, Thermal

Narrative

Description of Event or Problem

PT IS REPORTED TO HAVE DEVELOPED A BURN ON HER HEEL FOLLOWING TREATMENT WITH THE ANODYNE THERAPY HOME SYSTEM. PT DID NOT RECEIVE MEDICAL INTERVENTION AND HAS HEALED.

Additional Manufacturer Narrative

PT IS REPORTED TO HAVE DEVELOPED A BURN ON HER RIGHT HEEL FOLLOWING TREATMENT WITH THE ANODYNE HOME SYSTEM FOR A PERIOD OF 10-12 MINUTES. THIS DOES COMPLY WITH THE TREATMENT GUIDELINES PROVIDED IN THE IMPORTANT SAFETY AND INSTRUCTION MANUAL. THE UNIT WAS RETURNED FOR EVAL, AND FOUND TO BE OPERATING WITHIN 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. THIS ADVERSE EVENT IS BEING REPORTED AT THIS TIME AS A RESULT OF A CHANGE TO THE COMPANY DECISION TREE FOR REPORTABLE EVENTS.