EXOGEN ULTRASOUND BONE HEALING SYSTEM
Received May 31, 2019 · Event occurred Apr 15, 2019
Report 3010203571-2019-00002 · MDR key 8658150
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
54 YR
- Wound Infection
- Wound Infection
Narrative
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.
Description of Event or Problem
PER THE PATIENT, THE FIRST WEEK OF (B)(6) HE BEGAN TO NOTICE A SORE FORMING ON THE TOP OF HIS RIGHT FOOT DUE TO THE BOOT HE WAS PRESCRIBED TO WEAR. PATIENT BEGAN EXOGEN USE ON (B)(6) 2019. ON (B)(6) 2019, PATIENT GOT ERROR MESSAGE ON DEVICE READING "CALL CUSTOMER SERVICE." THE PATIENT CALLED CUSTOMER SERVICE, AND THE PATIENT DID NOT DISCLOSE TO BIOVENTUS REPRESENTATIVE ABOUT THE PRESENT SORE. PER THE PATIENT, THE REPRESENTATIVE INFORMED HIM THAT THE MESSAGE TYPICALLY APPEARS DUE TO POOR CONTACT AND ADVISED PATIENT TO TIGHTEN STRAP AS IT WOULD HELP TO AVOID MESSAGE IN THE FUTURE. THE PATIENT CONTINUED EXOGEN USE, AND EVERY TIME THE ERROR MESSAGE APPEARED HE WOULD TIGHTEN STRAP AND IT WOULD HELP ERROR MESSAGE GO AWAY. ON (B)(6) 2019, THE PATIENT NOTICED REDNESS ON HIS SORE. ON (B)(6) 2019, THE LAST DATE OF DEVICE USE, THE PATIENT CALLED THE DOCTOR ABOUT REDNESS AND DOCTOR ADVISED HIM TO STOP USE OF THE DEVICE. ON (B)(6) 2019 PATIENT WAS HOSPITALIZED FOR INFECTION AND WAS DISCHARGED (B)(6) 2019. GOOD FAITH ATTEMPTS WERE MADE BUT HAVE BEEN UNSUCCESSFUL TO DATE.