EXOGEN ULTRASOUND BONE HEALING SYSTEM

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WAS RECEIVED IDENTIFYING THE PRODUCT ASSOCIATED WITH THE EVENT. FURTHERMORE, THE TREATING PHYSICIAN CLASSIFIED THE EVENT AS NON-SERIOUS.

Additional Manufacturer Narrative

LOW-INTENSITY, PULSED ULTRASOUND IS NOT KNOWN TO CAUSE OR PROMOTE INFECTION IF USED CORRECTLY (I.E. NOT USED ON OR NEAR OPEN WOUNDS). THERE ARE SEVERAL REPORTS IN THE LITERATURE ON SUCCESSFUL EXOGEN USE IN THE PRESENCE OF INFECTION. THUS A DEEP INFECTION AT THE FRACTURE SITE IS HIGHLY UNLIKELY TO BE CAUSALLY RELATED TO THE USE OF EXOGEN. THE OCCURRENCE OF BLISTERS NEAR THE TRANSDUCER APPLICATION SITE COULD BE DUE TO SKIN REACTION TO THE GEL.

Description of Event or Problem

AS REPORTED BY THE DISTRIBUTOR ON 03 JUN 2019, THE EXOGEN PATIENT EXPERIENCED INFECTION AT THE APPLICATION SITE OF HIS DISTAL TIBIA. FOLLOW UP REVEALED THAT THE PATIENT WAS TREATING AT THE SITE OF AN OPEN WOUND AND DEVELOPED AN INFECTION AT THE APPLICATION SITE. THE APPLICATION SITE WAS MOVED AND THE PATIENT ALSO DEVELOPED A RED BLISTER AT THE NEW APPLICATION SITE. THE PHYSICIAN NOTED THAT CAUSALITY COULD NOT BE DENIED AND CLASSIFIED THE EVENT AS "NON-SERIOUS." THE AFFECTED TISSUE WAS EXAMINED VIA CULTURE BUT BACILLUS WERE NOT DETECTED. A MRI WAS PERFORMED AND THE RESULTS INDICATED CELLULITIS OF THE SUSPECTED AREA AROUND THE FRACTURE SITE. THE PATIENT WAS ALREADY IN THE HOSPITAL WHEN THE POSSIBLE INFECTION WAS NOTED AND EXTENSION OF HOSPITALIZATION WAS NOT REQUIRED FOR THE INFECTION. DURING HOSPITALIZATION, THE PATIENT RECEIVED A DRIP OF LEVOFLOXACIN AND WAS PRESCRIBED LEVOFLOXACIN TABLETS FOR AFTER DISCHARGE. THE PATIENT'S CURRENT STATUS WAS UNKNOWN AT THE TIME OF FOLLOW UP. AS STATED IN OUR IFU PATIENTS WITH INFECTIONS WERE NOT INCLUDED IN THE CLINICAL STUDIES USED FOR FDA APPROVAL. THEREFORE THE SAFETY AND EFFECTIVENESS OF EXOGEN IN INFECTIONS HAS NOT BEEN ESTABLISHED. USE IN THIS PATIENT POPULATION IS AT THE DISCRETION OF THE TREATING PHYSICIAN BASED ON A RISK/BENEFIT CONSIDERATION. LOW-INTENSITY, PULSED ULTRASOUND IS NOT KNOWN TO CAUSE OR PROMOTE INFECTION IF USED CORRECTLY (I.E. NOT USED ON OR NEAR OPEN WOUNDS). IT IS ALSO KNOWN AND ADDRESSED IN LABELING THAT SOME PATIENTS MAY EXPERIENCE HYPERSENSITIVITY TO THE ULTRASOUND COUPLING GEL, AND PATIENTS ARE ADVISED THAT THE EXOGEN ULTRASOUND SIGNAL WILL ALSO COUPLE TO THE SKIN USING MINERAL OIL. THERE ARE ALSO SEVERAL REPORTS IN LITERATURE ON SUCCESSFUL EXOGEN USE IN THE PRESENCE OF INFECTIONS. NO CORRECTIVE ACTION IS REQUIRED AS THERE IS NO HARM OR RISK IDENTIFIED FOR THE PATIENT OR USER.