InjuryILY
ANODYNE THERAPY
Received Jan 9, 2010
Report 1055581-2009-00005 · MDR key 1580003
Device
Generic name
Infrared Lamp
Manufacturer
Anodyne Therapy, LlcModel number
480Catalog number
498019
Lot number
NA
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Injury
Narrative
Additional Manufacturer Narrative
COMPANY HAS BEEN NOTIFIED THAT THE HOSPITAL HAS EXPERIENCED AN ADVERSE EVENT WHILE USING THIS ANODYNE SYSTEM. DETAILS OF THIS EVENT ARE UNKNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN SUFFICIENT INFORMATION IS AVAILABLE. UNIT HAS BEEN RETURNED FOR EVALUATION, AND WILL BE EVALUATED WHEN ALL INFORMATION OF THE ADVERSE EVENT ARE KNOWN.
Description of Event or Problem
COMPANY HAS BEEN NOTIFIED THAT THE HOSPITAL HAS EXPERIENCED AN ADVERSE EVENT WHILE USING ONE OF ITS ANODYNE SYSTEMS.