ANODYNE THERAPY
Received Sep 28, 2009 · Event occurred Feb 10, 2009
Report 1055581-2009-00002 · MDR key 1490247
Device
Generic name
Infrared Lamp
Manufacturer
Anodyne Therapy, LlcModel number
480Catalog number
498006
Lot number
NA
Product problems
- Insufficient Device Problem Information
Patient
UNK
- Partial thickness (Second Degree) Burn
Narrative
Description of Event or Problem
PT IS REPORTED TO HAVE DEVELOPED A SECOND DEGREE BURN ON THE BOTTOM OF THIS FOOT FOLLOWING TREATMENT WITH THE ANODYNE PROFESSIONAL MODEL.
Additional Manufacturer Narrative
PT IS REPORTED TO HAVE DEVELOPED A 2ND DEGREE BURN ON THE BOTTOM OF HIS FOOT FOLLOWING TREATMENT WITH THE ANODYNE THERAPY PROFESSIONAL MODEL. THE TREATING FACILITY RECORDS DO NOT INDICATE OBSERVANCE OF A BURN FOLLOWING TREATMENT. THEY WERE NOTIFIED OF THE INCIDENT BY THE PT IN 2009 AND THE LAST TREATMENT FOR THE PT WAS 6 MONTHS PRIOR. THE TREATING FACILITY REPORTS, TREATING THIS PT AT A TIME AND INTENSITY CONSISTENT WITH THE GUIDELINES PROVIDED IN THE IMPORTANT SAFETY AND INFO MANUAL. THE UNIT INVOLVED IN THIS INCIDENT HAS BEEN SHIPPED TO ANODYNE, BUT HAS NOT YET BEEN RECEIVED. ACCORDINGLY, TESTING HAS NOT YET BEEN COMPLETED. IT IS HIGHLY, LIKELY THAT THE UNIT IS PERFORMING WITHIN SPECIFICATION, SINCE THE FACILITY HAS CONTINUED TO TREAT PT WITHOUT INCIDENT SINCE THEN. THE NUMBER OF INCIDENTS OF THIS TYPE REMAIN WITHIN THE EXPECTED RATE FOR THIS PRODUCT, BASED UPON THE NUMBER OR INCIDENTS REPORTED AND THE NUMBER OF UNITS IN DISTRIBUTION. COMPANY CONTINUES TO MONITOR AND TREND EVENTS OF THIS TYPE.