LIGHTFORCE

Additional Manufacturer Narrative

IT WAS REPORTED THAT PATIENT WAS GIVEN DEEP TISSUE LASER THERAPY USING LIGHT FORCE LASER DEVICE. THERAPY WAS APPLIED TO THE LEFT SHOULDER AND LEFT UPPER ARM. WITHIN 20 MINUTES OF THERAPY THE PATIENT SUFFERED SEVERE PAIN IN THE UPPER ARM AREA. WITHIN 12 HOURS A SORE APPEARED ON THE PATIENT'S PALM. WITHIN 30 HOURS OF TREATMENT THE PATIENT EXPERIENCED BLISTERING ON THE UPPER ARM ALL THE WAY TO THE TIP AND SIDE OR TWO MIDDLE FINGERS. THE PATIENTS HAND BECAME SWOLLEN, AND THE PATIENT LOST USE OF THEIR ARM AND HAND DUE TO THE EXHIBITED SYMPTOMS. THE PATIENT IMMEDIATELY WENT TO THE DERMATOLOGIST AND WAS DIAGNOSED WITH SHINGLES TRIGGERED BY OVERSTIMULATION OF THE NERVE IN THE ARM. THE BLISTERING FOLLOWED THE NERVE PATH TO THE TIPS OF THE PATIENTS' MIDDLE FINGERS, THE PATIENT IS STILL RECOVERING AND THE FULL EXTENT OF THE DAMAGE DONE HAS NOT BEEN FULLY EVALUATED. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE ROOT CAUSE COULD NOT BE ESTABLISHED. ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT IF IT BECOMES AVAILABLE.

Description of Event or Problem

IT WAS REPORTED THAT PATIENT WAS GIVEN DEEP TISSUE LASER THERAPY USING LIGHT FORCE LASER DEVICE. THERAPY WAS APPLIED TO THE LEFT SHOULDER AND LEFT UPPER ARM. WITHIN 20 MINUTES OF THERAPY THE PATIENT SUFFERED SEVERE PAIN IN THE UPPER ARM AREA. WITHING 12 HOURS A SORE APPEARED ON THE PATIENT'S PALM. WITHIN 30 HOURS OF TREATMENT THE PATIENT EXPERIENCED BLISTERING ON THE UPPER ARM ALL THE WAY TO THE TIP AND SIDE OR TWO MIDDLE FINGERS. THE PATIENTS HAND BECAME SWOLLEN, AND THE PATIENT LOST USE OF THEIR ARM AND HAND DUE TO THE EXHIBITED SYMPTOMS. THE PATIENT IMMEDIATELY WENT TO THE DERMATOLOGIST AND WAS DIAGNOSED WITH SHINGLES TRIGGERED BY OVERSTIMULATION OF THE NERVE IN THE ARM. THE BLISTERING FOLLOWED THE NERVE PATH TO THE TIPS OF THE PATIENTS' MIDDLE FINGERS, THE PATIENT IS STILL RECOVERING AND THE FULL EXTENT OF THE DAMAGE DONE HAS NOT BEEN FULLY EVALUATED.