ISOLAZ 2 INTENSE PULSED LIGHT SYSTEM

Additional Manufacturer Narrative

THE DEVICE HAS NOT BEEN RETURNED TO SOLTA MEDICAL, THEREFORE, A PRODUCT EVALUATION HAS NOT BEEN CONDUCTED. THE USER FACILITY HAS CONFIRMED THAT THE DEVICE IS FUNCTIONING AS DESIGNED WITHOUT ANY TECHNICAL ISSUES. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO NON-CONFORMITIES OR ANOMALIES FOUND RELATED TO THE REPORTED EVENT. THE REPORTED ADVERSE EVENT IS A KNOWN PROCEDURE COMPLICATION OF ISOLAZ TREATMENT. BLISTERS ARE AN ANTICIPATED SIDE-EFFECT OF ISOLAZ TREATMENT.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT WAS TREATED ON THE FACE AND ONE TO TWO HOURS POST TREATMENT A BURN APPEARED ON THE LEFT CHEEK. THE HIGHEST POWER LEVEL USED WAS 3. THERE WERE NO SYSTEM ERRORS. THE PATIENT WAS SEEN BY A PHYSICIAN AT THE TREATING CLINIC SEVERAL DAYS AFTER THE BURN APPEARED. THE BURN IS APPROXIMATELY 1.5 CM BY 1 CM. THE PATIENT DID NOT UNDERGO SIGNIFICANT SUN EXPOSURE PRIOR TO OR DURING THE COURSE OF TREATMENT TO THE PHYSICIAN''S KNOWLEDGE - THE PATIENT IS RELATIVELY CAREFUL WITH SUN EXPOSURE. THE BURN WAS CLASSIFIED AS A SECOND DEGREE BURN WITH CRUSTING. THE PATIENT WAS PRESCRIBED DUODERM DRESSING FOR MOISTURE RETENTION. THE PHYSICIAN SUSPECTS THERE MAY BE POST-INFLAMMATORY HYPERPIGMENTATION BUT THERE MAY NOT BE A SCAR.

Additional Manufacturer Narrative

INVESTIGATION OF THIS EVENT IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.