VANQUISH

Description of Event or Problem

REPORTED THAT A FEMALE PATIENT TREATED BY VANQUISH COMPLAINED OF BURNS AND BLISTERS IN THE TREATED AREA. NO SIGNS OF INJURY IMMEDIATELY AFTER THE TREATMENT. THE FOLLOWING DAY INJURY APPEARED. PATIENT WAS SEEN BY MD AND WAS INSTRUCTED ON WOUND MANAGEMENT AND TO COVER WOUND WITH AQUAPHOR AND NEOSPORIN.

Additional Manufacturer Narrative

BTL INDUSTRIES FOLLOWED UP WITH THE PHYSICIAN'S OFFICE TO GATHER ADDITIONAL INFORMATION. PER THE PHYSICIAN'S OFFICE, PATIENT REPORTED FEW HOT SPOTS DURING THE TREATMENT. USER RESPONDED BY MOVING APPLICATOR AWAY AND/OR DECREASING ENERGY. AT THE END OF THE TREATMENT SOME MOISTURE WAS FELT ON THE PATIENT'S SKIN. PATIENT HAD NO COMPLAINTS OF PAIN OR ITCHING IN THE AREA. PATIENT SAW A BURN SPECIALIST AND WAS PRESCRIBED ANTIBIOTIC CREAM AND ANTIBIOTIC WRAP. SPECIALIST SAID THAT THE PATIENT HAS 1 SECOND DEGREE BURN AND 1 THIRD DEGREE BURN, MAKING THIS A REPORTABLE EVENT. BASED ON PHYSICIAN'S OFFICE INFORMATION, BURNS ARE HEALING. PER THE PHYSICIAN'S OFFICE, THE PROCEDURE ON (B)(6) 2014 WAS CONDUCTED SUCCESSFULLY WITH NO MALFUNCTION. BTL INDUSTRIES REVIEWED THE SYSTEM LOGS FOR THE TREATMENT DATE AND CONFIRMED THAT NO SYSTEM MALFUNCTION OCCURRED.