inforMED
InjuryILY

ANODYNE THERAPY

Received Nov 19, 2007 · Event occurred Aug 27, 2007

Report 1055581-2007-00020 · MDR key 951500

Device

Generic name

Infrared Lamp

Model number

480

Catalog number

498005

Lot number

NA

Product problems

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

Patient

67 YR

  • Therapy/non-surgical treatment, additional
  • Burn, Thermal

Narrative

Additional Manufacturer Narrative

THERAPIST REPORTED TREATING THIS PT WITHIN THE GUIDELINES PROVIDED IN OUR IMPORTANT SAFETY INFORMATION AND INSTRUCTION MANUAL. THE UNIT INVOLVED IN THIS EVENT HAS BEEN RETURNED FOR EVALUATION. THE UNIT WAS FOUND TO BE OUT OF OPERATING SPECIFICATIONS, BUT THESE FINDINGS WOULD NOT HAVE CAUSED THIS EVENT. 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 KIND.

Description of Event or Problem

PT IS REPORTED TO HAVE DEVELOPED A BURN ON HIS RIGHT CALF FOLLOWING TREATMENT WITH THE ANODYNE SYSTEM, ADMINISTERED BY A HEALTH CARE PROFESSIONAL. THE PT WAS TREATED FOR THE BURN BY HIS PHYSICIAN.