LUMECCA

Additional Manufacturer Narrative

THIS CASE IS REPORTED FOLLOWING RETROSPECTIVE REVIEW AND RE-ASSESSMENT OF THE CASE'S SERIOUSNESS. PATIENT PRESENTED WITH FIRST AND SECOND DEGREE BURNS SPREAD OVER HER RIGHT ARM FOLLOWING LUMECCA TREATMENT. INMODE RECOMMENDED THE PATIENT TO VISIT GP FOR DRAINING THE BLISTER AND APPLY ADDITIONAL PRODUCTS TO KEEP THE SKIN MOIST AND TO PROMOTE GOOD HEALING. ALTHOUGH WE DO NOT HAVE THE INFORMATION WHETHER THE PATIENT EVENTUALLY VISITED A PHYSICIAN OR NOT TO ADDRESS THE BLISTER, DUE TO THE NECESSITY OF SUCH INTERVENTION, THE ADVERSE EVENT IS BEING REPORTED. PER LATEST UPDATE RECEIVED AT INMODE, THE BURNS HEALED AND THE PATIENT WAS PRESENTING WITH PIGMENTATION CHANGES, ASSUMED TO BE TRANSIENT. INVESTIGATION CONCLUDED THE ROOT-CAUSE TO BE A USER ERROR: THE OPERATOR DID NOT PERFORM A PATCH TEST AS REQUIRED BY IFU AND APPLIED A VERY HIGH FLUENCE, NOT SUITABLE FOR THE PATIENT'S SKIN TYPE. ADDITIONALLY, THE TREATMENT PROVIDER APPLIED IPL WITH HIGH OVERLAP, ADDING TO THE THERMAL DAMAGE TO THE SKIN. THE CLINIC WAS RETRAINED.

Description of Event or Problem

BURNS ON ARM FOLLOWING LUMECCA TREATMENT.