EXOGEN ULTRASOUND BONE HEALING SYSTEM

Additional Manufacturer Narrative

H10: A REVIEW OF SUBMITTED REPORTS IDENTIFIED MISSING INFORMATION. THIS FOLLOW UP WAS COMPLETED TO ADDRESS THE MISSING INFORMATION.

Additional Manufacturer Narrative

THE REPORTED EVENT ALLEGES INFECTION AND RASH WITH THE USE OF THE EXOGEN GEL, A COUPLING MEDIUM USED WITH THE EXOGEN BONE HEALING SYSTEM. EXOGEN LABELING INDICATES THE GEL IS A NON-STERILE PRODUCT THAT SHOULD NOT BE USED ON PATIENTS WHO HAVE OPEN WOUNDS. ADDITIONALLY, SOME PATIENTS MAY EXPERIENCE MILD SKIN IRRITATION DUE TO HYPERSENSITIVITY TO THE GEL. IN THE EVENT THE PATIENT DOES EXPERIENCE SENSITIVITY TO THE GEL, THE PATIENTS ARE ADVISED TO SWITCH TO ANOTHER COUPLING AGENT SUCH AS MINERAL OIL OR GLYCERIN. THE ROOT CAUSE OF THE EVENT IS UNKNOWN, HOWEVER THE APPLICATION SITE RASHES ARE NOT INDICATIVE OF A PRODUCT ISSUE AND CAN BE ATTRIBUTED TO PATIENT HYPERSENSITIVITY. THE MICROBES FOR THE INFECTION CANNOT BE CONFIRMED OR LINKED TO THE USE OF THE GEL.

Description of Event or Problem

IT WAS REPORTED A PATIENT PRESCRIBED THE EXOGEN DEVICE AND EXOGEN GEL FOR TREATMENT OF A TIBIA FRACTURE PRESENTED EMERGENTLY WITH A FEVER OF 37.8 DEGREES C AND AN INFECTION IN THEIR LEG. THE PATIENT WAS TREATED WITH LEVOFLOXACIN AND A CEFAZOLIN SODIUM INJECTION. THE PATIENT ALSO UNDERWENT DEBRIDEMENT OF THE INFECTION SITE 3 DAYS FOLLOWING THE ANTIBIOTIC TREATMENT. ADDITIONALLY, IT WAS REPORTED THE PATIENT HAD ALSO BEEN USING THE EXOGEN DEVICE TO TREAT ADDITIONAL PARTS OF THEIR BODY. AN OBSERVATION OF ADDITIONAL RASHES IN THE SHAPE OF A BAND WERE VISIBLE AT THESE OTHER TREATMENT SITES. THE PATIENT WAS GIVEN GENTAMICIN OINTMENT TO TREAT THE RASH. THE PATIENT DID COMPLETE BLOODWORK AT THE TIME OF THE EVENT, HOWEVER, CULTURES WERE NOT COMPLETED. A SPECIFIC BACTERIA WAS NOT IDENTIFIED AND THE CAUSE OF THE INFECTION IS UNKNOWN. THE CURRENT PATIENT STATUS IS UNKNOWN.