InjuryILY
LIGHT RELIEF
Received Dec 19, 2013 · Event occurred Dec 8, 2013
Report MW5033541 · MDR key 3532947
Device
Generic name
Infrared Light Therapy
Manufacturer
Light ReliefProduct problems
- Inadequate Instructions for Healthcare Professional
Patient
68 YR
- Erythema
- Muscle Weakness/Atrophy
- Pain
- Skin Discoloration
- Burn, Thermal
Narrative
Description of Event or Problem
PT STATED THAT HE EXPERIENCED MULTIPLE DEEP SLOW BURNS WHILE USING HIS LIGHT RELIEF THERAPY FOR MUSCLE PAIN. HE DESCRIBED THE BURNS AS HALF A THUMB TACK SIZE ALL OVER HIS BACK AND CHEST. HE STATED THAT THE BURNS WERE RED THE FIRST DAY AND TURNED BLACK ON THE SECOND DAY. HE STATED THAT THE BURNS ARE VERY PAINFUL AND FEEL AS THOUGH THEY ARE DEEP INTO HIS MUSCLE AND BONE. HE ALSO STATED THAT HE HAS RIGHT SHOULDER AND ARM WEAKNESS. HE ALLEGED THAT THE DEVICE DOES NOT HAVE ADEQUATE WARNING LABELS. HE STATED THAT HE PLANS TO SEE A PHYSICIAN.