inforMED
InjuryILY

ANODYNE THERAPY

Received Aug 27, 2007 · Event occurred Aug 1, 2007

Report 1055581-2007-00011 · MDR key 905348

Device

Generic name

Infrared Lamp

Model number

120

Catalog number

498003

Lot number

NA

Product problems

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

Patient

80 YR

  • Pain
  • Improved patient condition
  • Burn, Thermal
  • Treatment with medication(s)

Narrative

Description of Event or Problem

PATIENT IS REPORTED TO HAVE DEVELOPED A BURN ON HER THIGH FOLLOWING AN HOUR OF TREATMENT WITH THE ANODYNE THERAPY HOME SYSTEM FOR LEG PAIN. THE PATIENT HAS RECEIVED MEDICAL TREATMENT OF ALTABAX AND SILVADENE, AND IS HEALING.

Additional Manufacturer Narrative

THIS PATIENT'S HUSBAND REPORTED THAT HE APPLIED HIS ANODYNE THERAPY SYSTEM TO HIS WIFE'S THIGH TO TREAT HER LEG PAIN. HE REPORTED THAT HE TREATED FOR ONE HOUR WHICH EXCEEDS THE 45 MINUTE MAXIMUM GUIDELINE PROVIDED IN THE IMPORTANT SAFETY INFORMATION AND INSTRUCTIONS MANUAL. THIS UNIT WAS RETURNED FOR EVALUATION, AND WAS FOUND TO BE OPERATING WITHIN SPECIFICATIONS. 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 PURPOSES.