ANODYNE THERAPY
Received Sep 25, 2007 · Event occurred Aug 29, 2007
Report 1055581-2007-00016 · MDR key 920602
Device
Generic name
Infrared Lamp
Manufacturer
Anodyne Therapy, LlcModel number
480Catalog number
498005
Lot number
NA
Product problems
- Unknown (for use when the device problem is not known)
Patient
80 YR
- Blister(s)
- Improved patient condition
- Treatment with medication(s)
Narrative
Description of Event or Problem
PATIENT IS REPORTED TO HAVE DEVELOPED A BLISTER ON HIS CALF, APPROXIMATELY 1CM IN DIAMETER, FOLLOWING TREATMENT WITH THE ANODYNE THERAPY PROFESSIONAL UNIT. TREATMENT WAS ADMINISTERED BY A HEALTH CARE PROFESSIONAL. PATIENT WAS TREATED WITH A TRIPLE ANTIBIOTIC OINTMENT, AND HAS HEALED.
Additional Manufacturer Narrative
TREATING FACILITY REPORTED THAT THEY TREATED THIS PATIENT WITH DIABETIC PERIPHERAL NEUROPATHY FOR 20 MINUTES AT AN ENERGY SETTING OF 10, FOLLOWED BY 10 MINUTES AT A REDUCED ENERGY SETTING OF 6. THE DAY FOLLOWING THIS TREATMENT, THE PATIENT EXHIBITED A BLISTER ON THE CALF, MEASURING APPROXIMATELY 1CM IN DIAMETER. THESE TREATMENT SETTING EXCEED THOSE PROVIDED IN OUR IMPORTANT SAFETY INFORMATION AND INSTRUCTION MANUAL. THE UNIT INVOLVED IN THIS INCIDENT HAS BEEN RETURNED FOR EVALUATION, WITH NO DEFECTS. 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 TENDING PURPOSES.