BIOVENTUS EXOGEN 4000J MOU ASSEMBLY

Description of Event or Problem

AVERSE EVENT: CUTANEOUS ULCER. PER (B)(4), THE PRESCRIBING PHYSICIAN RECOGNIZED A CUTANEOUS ULCER WHEN HE REMOVED THE MEDICAL TAPE FROM THE PATIENT'S AFFECTED AREA (LEFT HUMERUS). THE PT WAS TREATING HER LEFT HUMERUS WITH EXOGEN DEVICE. NO MALFUNCTION OF THE DEVICE WAS REPORTED AS TREATMENT IS STILL CONTINUING WITH NO TROUBLE. ADVERSE EVENT: CUTANEOUS ULCER. PER (B)(4), THE PRESCRIBING PHYSICIAN RECOGNIZED A CUTANEOUS ULCER WHEN HE REMOVED THAT MEDICAL TAPE FROM THE PATIENT'S AFFECTED AREA (LEFT HUMERUS). THE PT WAS TREATING HER LEFT HUMERUS WITH EXOGEN DEVICE. THE DOCTOR RECOGNIZED THE WOUND HEALING ON (B)(6) 2014. NO MALFUNCTION OF THE DEVICE WAS REPORTED AS TREATMENT IS STILL CONTINUING WITH NO TROUBLE.

Additional Manufacturer Narrative

ACCORDING TO THE TREATING PHYSICIAN, THIS EVENT IS SERIOUS AND RELATED TO THE USE OF EXOGEN. A MEDICAL REVIEW WAS PERFORMED BY BOTH (B)(4) AND BIOVENTUS. NONE AGREES THAT THIS INCIDENT IS RELATED TO THE DEVICE. SKIN ULCERS MIGHT OCCUR DUE TO COMPONENTS OF THE CAST OR TAPE SUCH AS TRAPPED HUMIDITY UNDER THE TAPE OR CAST. THE EXOGEN ULTRASOUND DEVICE SIGNAL IS TOO WEAK TO CAUSE ANY SKIN OR TISSUE DAMAGE. THE PACKAGE INSERT OF THIS DEVICE STATES THAT THE UNIT SHOULD BE USED UNDER OBSERVATION DURING TREATMENT FOR OPERATIVE WOUNDS AND EXTERNAL WOUNDS. IF SKIN TROUBLE IS RECOGNIZED THEN THE PT MUST STOP USING THE DEVICE.