ANODYNE THERAPY
Received Mar 23, 2007 · Event occurred Jan 23, 2007
Report 1055581-2007-00004 · MDR key 831010
Device
Generic name
Infrared Lamp
Manufacturer
Anodyne Therapy, LlcModel number
480Catalog number
4980006
Lot number
NA
Product problems
- Unknown (for use when the device problem is not known)
Patient
74 YR
- Blister(s)
- Treatment with medication(s)
Narrative
Additional Manufacturer Narrative
THE UNIT INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION, AND DUTY CYCLE FAILURE WAS DETECTED. THE DESIGN AND FUNCTIONALITY OF ANODYNE'S DEVICE DOES NOT SUGGEST THAT THERE IS AN ANTICIPATED OR "USUAL" FREQUENCY AND SEVERITY OF OCCURRENCE FOR THE INCIDENT REPORTED IN THIS MDR.
Description of Event or Problem
PATIENT IS REPORTED TO HAVE DEVELOPED A BLISTER ON HIS LEFT CALF, APPROXIMATELY 1 CM IN DIAMETER, FOLLOWING TREATMENT WITH A ANODYNE PROFESSIONAL SYSTEM, ADMINISTERED BY A HEALTHCARE PROFESSIONAL. PATIENT TREATED THE BLISTER WITH AN OVER THE COUNTER OINTMENT - BACTERIN, AND IS HEALING.