ANODYNE THERAPY
Received Aug 31, 2007 · Event occurred Jul 27, 2007
Report 1055581-2007-00012 · MDR key 906679
Device
Generic name
Infrared 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
69 YR
- Therapy/non-surgical treatment, additional
- Burn, Thermal
- Treatment with medication(s)
Narrative
Additional Manufacturer Narrative
PT REPORTS THAT SHE RECEIVED BURNS ON HER HEELS FOLLOWING TREATMENT WITH THE ANODYNE HOME SYSTEM FOR 25-30 MINUTES. THIS IS WITHIN THE TREATMENT GUIDELINES PROVIDED IN THE IMPORTANT SAFETY INFO AND INSTRUCTION MANUAL. PT HAS APPLIED TREATMENTS USING THE SAME PROTOCOL FOR TWO YEARS WITHOUT INCIDENT. THIS UNIT WAS RETURNED FOR EVALUATION, AND WAS FOUND TO BE OPERATING WITHIN SPECIFICATION. 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.
Description of Event or Problem
PT IS REPORTED TO HAVE DEVELOPED BURNS ON HER HEELS FOLLOWING TREATMENT WITH THE ANODYNE HOME SYSTEM. PT HAS RECEIVED MEDICAL INTERVENTION; HER DOCTOR HAS PRESCRIBED BACITRACIN AND DRESSINGS.