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 DOCTOR AND WAS PRESCRIBED TOPICAL BURN CREAM SILVADENE AND ANTIBIOTIC DORYX - 125 MG.

Additional Manufacturer Narrative

BTL INDUSTRIES FOLLOWED UP WITH THE PHYSICIAN'S OFFICE TO GATHER ADDITIONAL INFORMATION. PER THE PHYSICIAN'S OFFICE PATIENT REPORTED HOT SPOTS DURING THE TREATMENT. AND ALSO, PATIENT REPORTS THAT SHE DID TRY TO "TOUGH IT OUT" EVEN WHEN THE TREATMENT WAS GETTING A LITTLE TOO HOT. PER THE INFORMATION PROVIDED BY PHYSICIAN OFFICE, THE PROCEDURE ON (B)(6) 2013 WAS CONDUCTED WITH NO MALFUNCTIONS. BTL INDUSTRIES REVIEWED THE SYSTEM LOGS FOR THE TREATMENT DATE AND CONFIRMED THAT NO SYSTEM MALFUNCTION OCCURRED. A F/U REPORT WILL BE MADE TO THE AGENCY IF AND WHEN NEW INFORMATION IS RECEIVED ABOUT THIS CASE.