LS PRO SYSTEMS LOW LEVEL LIGHT THERAPY

Description of Event or Problem

PRODUCT OVERHEATED AND BURNT PATIENT DURING USE. THE LOW LEVEL LASER THERAPY WAS ADVERTISED AS FDA APPROVED DURING TRADE SHOW. IT HAS COME TO MY ATTENTION UNDER FURTHER INVESTIGATION. THE UNITS WERE FDA APPROVED AND HAVE HAD 3 INCIDENTS OF OVERHEATING. THIS HAS BEEN THE MOST SIGNIFICANT. NAME AND STRENGTH: LSG 264, NOT SURE ANYMORE UNK. DOSE OR AMOUNT: 2AN; FREQUENCY: DAILY. DATES OF USE: (B)(6) 2018 TO (B)(6) 2018. DIAGNOSIS OR REASON FOR USE: TO HEAL PATIENT'S WOUNDS. "IS THE PRODUCT COMPOUNDED: NO. IS THE PRODUCT OVER-THE-COUNTER: NO." EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES. EVENT REAPPEARED AFTER REINTRODUCTION: YES.