ANODYNE THERAPY
Received Apr 2, 2008 · Event occurred Dec 21, 2007
Report 1055581-2008-00002 · MDR key 1025675
Device
Generic name
Infrared Lamp
Manufacturer
Anodyne Therapy, LlcModel number
480Catalog number
498006
Lot number
NA
Product problems
- Unknown (for use when the device problem is not known)
Patient
58 YR
- Blister(s)
Narrative
Description of Event or Problem
A DEFECTIVE 555 TIMER WAS IDENTIFIED ON AN ANODYNE PROFESSIONAL UNIT THAT WAS RETURNED FOR EVAL. THE HEALTH CARE PROFESSIONAL REPORTED A PATIENT HAD DEVELOPED A BLISTER ON HER CALF FOLLOWING TREATMENT WITH THE UNIT. PATIENT DID NOT REQUIRE MEDICAL INTERVENTION.
Additional Manufacturer Narrative
THERAPIST REPORTED TREATING THIS PATIENT FOR 30 MINUTES AT AN ENERGY SETTING OF 8 WHICH IS WITHIN THE RECOMMENDED GUIDELINES. PATIENT DID NOT REQUIRE MEDICAL INTERVENTION. THE UNIT INVOLVED IN THIS INCIDENT WAS RETURNED FOR EVAL. A DEFECTIVE TIMER WAS IDENTIFIED WHICH CAUSED THE THERAPY PAD TEMPERATURES TO EXCEED SPECIFICATIONS. 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 NATURE.