EXOGEN ULTRASOUND BONE HEALING SYSTEM

Additional Manufacturer Narrative

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

Additional Manufacturer Narrative

H10: UPDATED A2, B4, G3. ADDITIONAL MANUFACTURER NARRATIVE: THE REQUIRED FOLLOW UP ATTEMPTS HAVE BEEN COMPLETED. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP REPORT WILL BE COMPLETED. BIOVENTUS WILL CONTINUE TO MONITOR AND TRACK THIS AND SIMILAR EVENTS.

Additional Manufacturer Narrative

H10: ADDITIONAL INFORMATION: UPDATES WERE MADE TO THE FOLLOWING SECTIONS: B4, B5: UPDATED WITH ADDITIONAL INFORMATION RECEIVED, G6, H6: TYPE OF INVESTIGATION CODE UPDATED.; ADDITIONAL MANUFACTURER NARRATIVE: ADDITIONAL INFORMATION REGARDING THIS EVENT WAS RECEIVED BY THE PHYSICIAN. THE PHYSICIAN INDICATED THE PATIENT HAD A RASH RESOLVING WITHIN FOUR DAYS OF THE PATIENT INITIALLY REPORTING THE RASH. THE PHYSICIAN CONFIRMED THE RASH WAS NOT LOCATED NEAR THE TREATMENT SITE AND HIGHLY UNLIKELY RELATED TO THE USE OF THE ULTRASOUND GEL. THE PHYSICIAN CONFIRMED THE PATIENT DID NOT HAVE AN INFECTION. THE EVENT HAS BEEN CORRECTED TO REFLECT A MINOR INJURY TO THE PATIENT. EXOGEN LABELING DOES INDICATE THERE ARE PATIENTS WHO EXPERIENCE SENSITIVITY TO THE USE OF THE ULTRASOUND GEL. IN CASES WHERE PATIENTS DO HAVE SENSITIVITY TO THE GEL, THEY ARE INSTRUCTED TO USE AN ALTERNATE COUPLING MEDIUM, MINERAL OIL, TO CONTINUE TREATMENT. BASED ON THE INFORMATION PROVIDED A SERIOUS ADVERSE EVENT DID NOT OCCUR. THE PATIENT DID NOT HAVE AN INFECTION AND THE RASH EXPERIENCED BY THE PATIENT IS A MINOR INJURY POSSIBLY NOT RELATED TO THE USE OF THE GEL. NO FURTHER ACTION IS REQUIRED AT THIS TIME, BIOVENTUS WILL CONTINUE TO MONITOR THESE TYPES OF EVENTS. H11: CORRECTIONS: H6: CLINICAL CODE CORRECTED, IMPACT CODE CORRECTED, INVESTIGATION FINDINGS CODE CORRECTED, AND CONCLUSION CODE CORRECTED.

Description of Event or Problem

ADDITIONAL INFORMATION RECEIVED FROM THE PHYSICIAN WHO INDICATED THE PATIENT DID NOT HAVE AN INFECTION. THE PATIENT HAD A RASH IN WHICH THE PHYSICIAN DOES NOT BELIEVE IT IS RELATED TO THE USE OF THE EXOGEN GEL. THE PHYSICIAN ALSO INDICATED THE RASH WAS NOT LOCATED NEAR THE TREATMENT SITE AND RESOLVED SPOTANEOUSLY 4 DAYS AFTER IT WAS REPORTED.

Additional Manufacturer Narrative

BASED ON THE INFORMATION AVAILABLE, NO DEFINITIVE CONCLUSIONS CAN BE MADE IN REGARDS TO THE REPORTED EVENT. ATTEMPTS FOR ADDITIONAL INFORMATION ARE IN PROGRESS. IT IS UNKNOWN IF THE PATIENT WAS TREATING ON AN OPEN WOUND. LABELING INSTRUCTS USERS THAT THE ULTRASOUND GEL IS NON-STERILE AND THAT IT SHOULD NOT BE USED ON AN OPEN WOUND.

Description of Event or Problem

IT WAS REPORTED A PATIENT USING THE EXOGEN SYSTEM EXPERIENCED BLISTERS, RED RASH AND ITCHING DURING TREATMENT. THE PATIENT WENT TO THE HOSPITAL TWO TIMES DUE TO POSSIBLE INFECTION. IT IS UNKNOWN IF THE PATIENT HAD INTERVENTION TO TREAT HER SYMPTOMS. THE TYPE OF INFECTION THE PATIENT HAD IS UNKNOWN. THE CURRENT PATIENT STATUS IS UNKNOWN.