ANODYNE THERAPY
Received Jun 30, 2008 · Event occurred Jun 5, 2008
Report 1055581-2008-00004 · MDR key 1070348
Device
Generic name
Infrared Lamp
Manufacturer
Anodyne Therapy, LlcModel number
480Catalog number
498006
Lot number
NA
Product problems
- Defective Device
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
CUSTOMER REPORTED THAT THEIR ANODYNE SYSTEM WAS WORKING ONLY ON ONE SIDE. WE REQUESTED THEY RETURN THEIR SYSTEM FOR EVALUATION, AND THE DUTY CYCLE WAS FOUND TO BE DEFECTIVE. THERE WAS NO ADVERSE EVENT REPORTED.
Additional Manufacturer Narrative
THE SYSTEM INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION AND DUTY CYCLE FAILURE WAS DETECTED. NO ADVERSE EVENT WAS REPORTED, HOWEVER THIS TYPE OF MALFUNCTION COULD POTENTIALLY CAUSE AN ADVERSE EVENT. 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.