ANODYNE
Received Dec 2, 2009 · Event occurred Oct 6, 2009
Report 1553686 · MDR key 1553686
Device
Generic name
Light Therapy Device
Manufacturer
Anodyne TherapyModel number
480Catalog number
*
Lot number
*
Product problems
- Output above Specifications
- Self-Activation or Keying
Patient
82 YR
- Erythema
- Burning Sensation
- Partial thickness (Second Degree) Burn
Narrative
Description of Event or Problem
PATIENT WAS RECEIVING THERAPY FROM AN ANODYNE LIGHT THERAPY UNIT. PATIENT'S LEG WAS BEING TREATED. PATIENT COMPLAINED OF BURNING SENSATION. PT CHECKED THE INTENSITY AND IT HAD "SELF BUMPED" UP TO 90% FROM THE ORIGINAL SETTING OF 80%. PATIENT HAD MILD REDNESS AND HAD 3 BLISTERS OF APPROXIMATELY 3CM WHEN CHECKED 3 DAYS LATER. THE PATIENT WAS NOT NOTED TO HAVE ANY SKIN INTEGRITY ISSUES. THE DEVICE WAS RETURNED FOR SERVICE TO THE MANUFACTURER. A SERVICE REPORT WAS NOT RELEASED TO OUR FACILITY, BUT THE MANUFACTURER INFORMED US THAT A POTENTIOMETER WAS REPLACED.
Description of Event or Problem
PATIENT WAS RECEIVING THERAPY FROM AN ANODYNE LIGHT THERAPY UNIT. PATIENT'S LEG WAS BEING TREATED. PATIENT COMPLAINED OF BURNING SENSATION. PT CHECKED THE INTENSITY AND IT HAD "SELF BUMPED" UP TO 90% FROM THE ORIGINAL SETTING OF 80%. PATIENT HAD MILD REDNESS AND HAD 3 BLISTERS OF APPROXIMATELY 3CM WHEN CHECKED 3 DAYS LATER. THE PATIENT WAS NOT NOTED TO HAVE ANY SKIN INTEGRITY ISSUES. THE DEVICE WAS RETURNED FOR SERVICE TO THE MANUFACTURER. A SERVICE REPORT WAS NOT RELEASED TO OUR FACILITY, BUT THE MANUFACTURER INFORMED US THAT A POTENTIOMETER WAS REPLACED.