VANQUISH

Additional Manufacturer Narrative

BTL INDUSTRIES FOLLOWED UP WITH THE PHYSICIAN´S OFFICE TO GATHER ADDITIONAL INFORMATION. BASED ON INFORMATION RECEIVED NO ERRORS OR DEVICE MALFUNCTION OCCURRED DURING THE TREATMENT. THE SYSTEM LOGS WERE REVIEWED FOR THE TREATMENT DATE AND CONFIRMED THAT NO SYSTEM MALFUNCTION OCCURRED DURING THE TREATMENT. BURNS ARE LISTED IN THE OPERATOR´S MANUAL AS A POTENTIAL ADVERSE EFFECT. THE PATIENT IS TREATED BY THE WOUND CARE SPECIALIST. AS OF (B)(6) 2015 THE INJURY IS NOT GETTING BETTER. A F/U REPORT WILL BE MADE TO THE AGENCY IF AND WHEN NEW INFORMATION IS RECEIVED ABOUT THIS CASE.

Description of Event or Problem

IT WAS REPORTED THAT A FEMALE PATIENT TREATED BY VANQUISH TO LOWER BACK COMPLAINED OF BURN IN THE TREATED AREA. PATIENT IS TREATED FOR WOUND WITH BURN COOLING PATCHES, BACITRACIN AND IBUPROFEN. PATIENT WAS SEEN BY URGENT CARE HOSPITAL. SHE WAS DIAGNOSED WITH 3RD DEGREE BURN. PATIENT WAS REFERRED TO WOUND CARE SPECIALIST.