ANODYNE THERAPY
Received Aug 11, 2009 · Event occurred Jul 9, 2009
Report 1055581-2009-00001 · MDR key 1439496
Device
Generic name
Infrared Lamp
Manufacturer
Anodyne Therapy, LlcModel number
480Catalog number
498015
Lot number
NA
Product problems
- Improper or Incorrect Procedure or Method
Patient
UNK
- Partial thickness (Second Degree) Burn
Narrative
Description of Event or Problem
PATIENT DEVELOPED A SECOND DEGREE BURN ON THE SHOULDER FOLLOWING TREATMENT WITH THE ANODYNE PROFESSIONAL MODEL. TREATING FACILITY REPORTS THIS CASE CAUSED BY APPLICATION FOLLOWING USE OF A DURAGESIC PAIN PATCH.
Additional Manufacturer Narrative
PATIENT IS REPORTED TO HAVE DEVELOPED A 2ND DEGREE BURN ON THE SHOULDER FOLLOWING TREATMENT WITH THE ANODYNE THERAPY PROFESSIONAL MODEL. THE TREATING FACILITY REPORTS TREATING AFTER THE AFFECTED SHOULDER AREA WAS TREATED WITH A DURAGESIC PAIN PATCH. ANODYNE CAUTIONS USERS NOT TO APPLY THERAPY PADS OVER AREAS TREATED WITH TOPICAL AGENTS. THIS CAUTION IS AFFIXED TO THE UNIT, AND IS ALSO PRINTED IN THE IMPORTANT SAFETY AND INFORMATION MANUAL WHICH IS PROVIDED WITH EACH UNIT. DETAILS OF THE INCIDENT ARE NOT AVAILABLE AT THIS TIME, AND SO A FOLLOW UP REPORT WILL BE FILED AT A LATER DATE WHEN THIS INFORMATION IS AVAILABLE.