EXOGEN ULTRASOUND BONE HEALING SYSTEM

Additional Manufacturer Narrative

THE CASE WAS REVIEWED BY BIOVENTUS CHIEF MEDICAL ADVISOR. HE STATED IT APPEARED THE PATIENT SUFFERED FROM A VERY RARE ALLERGIC RESPONSE TO THE GEL. THE PATIENT WAS ADVISED TO DISCONTINUE USE OF THE GEL AND USE MINERAL OIL AS A COUPLING AGENT. WE FOLLOWED UP WITH THE PATIENT ON (B)(6) 2015 AND HE STATED HE HAS RECOVERED FROM THE HIVES. HE IS STILL USING THE DEVICE AND IS USING MINERAL OIL. HE HAS HAD NO REACTION TO THE MINERAL OIL. ACCORDING TO THE INSTRUCTIONS FOR USE, SOME PATIENTS MAY EXPERIENCE MILD SKIN IRRITATION CAUSED BY SKIN SENSITIVITY TO THE GEL. IT IS RECOMMENDED THAT THE PATIENT SWITCH TO MINERAL OIL AS A COUPLING AGENT. TO DATE, THIS IS THE SECOND CASE RECEIVED FOR EXOGEN BIOVENTUS ULTRASOUND GEL WHERE THE PATIENT SUFFERED A MORE SEVERE CASE OF HIVES. HYPERSENSITIVITY TO THE GEL IS A KNOWN ADVERSE EVENT AND TYPICALLY NOT SERIOUS; HOWEVER, IN THIS CASE, IS DEEMED REPORTABLE AS IT IS MORE SERIOUS AND AS THE PATIENT EXPERIENCED A SEVERE REACTION AND SOUGHT TREATMENT.

Description of Event or Problem

ADVERSE EVENT-HIVES. THE PATIENT CONTACTED BIOVENTUS ON (B)(6) 2015 STATING THAT HE BROKE OUT IN HIVES AND IS ATTRIBUTING THIS EVENT TO THE BIOVENTUS ULTRASOUND GEL. THE PATIENT RECEIVED THE EXOGEN SYTEM ON (B)(6) 2015 FOR A BROKEN FEMUR. HE USED THE EXOGEN DEVICE AND THE BIOVENTUS ULTRASOUND GEL AS A COUPLING AGENT FOR ABOUT 2 WEEKS AND HAD NO REACTION. ON (B)(6) 2015, HE EXPERIENCED ITCHING AND SKIN BREAK OUTS ON ABOUT 50% OF HIS BODY. THIS REACTION STARTED BEFORE HE BEGAN THE EXOGEN TREATMENT. ON (B)(6) 2015, HIS BODY WAS 90% COVERED WITH WHAT APPEARED TO BE HIVES. HIS GUMS AND TONGUE WAS SWOLLEN. HE COULD NOT CLOSE HIS MOUTH DUE TO THE SWELLING. HE ALSO HAD WELTS IN THE BACK OF HIS HEAD. HE TOOK BENADRYL FOR THE ITCHING AND SKIN REACTION. HE DID NOT GET MUCH RELIEF FROM THE BENADRYL. ON (B)(6) 2015, HE WENT TO AN URGENT CARE CENTER. THE PHYSICIAN TOOK PICTURES OF THE HIVES/REACTION. THE URGENT CARE DOCTOR GAVE THE PATIENT A SHOT, AND PRESCRIBED HIM METHYLPREDNISOLONE 4MG, 21 TABLETS AND HYDROXYZINE HCL 25MG, 1 TAB BY MOUTH 3 TIMES DAILY AS NEEDED (ANTI-ITCH PILLS). HE BEGAN TAKING THE PILLS THE SAME DAY. HE STOPPED TREATMENT WITH THE EXOGEN DEVICE FOR 3 DAYS (SATURDAY, SUNDAY AND MONDAY). THE PATIENT'S WIFE REFERRED TO THE USER MANUAL THAT STATES MINERAL OIL CAN BE USED IN PLACE OF THE BIOVENTUS ULTRASOUND GEL. ON (B)(6) 2015, THE PATIENT BEGAN TO USE THE EXOGEN DEVICE AND USED MINERAL OIL IN PLACE OF THE BIOVENTUS ULTRASOUND GEL.