EXOGEN ULTRASOUND BONE HEALING SYSTEM
Received Oct 8, 2021 · Event occurred Jun 23, 2020
Report 3010203571-2021-00012 · MDR key 12600500
Device
Generic name
Exogen
Manufacturer
Bioventus LlcModel number
71034400Catalog number
71034400
Lot number
20CM15740
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
44 YR
- Unspecified Infection
- Unspecified Infection
Narrative
Additional Manufacturer Narrative
BASED ON THE INFORMATION AVAILABLE, NO DEFINITIVE CONCLUSIONS CAN BE MADE IN REGARDS TO THE REPORTED EVENT. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE. A FOLLOW UP REPORT WILL BE SUBMITTED IF NEW INFORMATION IS RECEIVED.
Description of Event or Problem
IT WAS REPORTED A PATIENT PRESCRIBED THE EXOGEN SYSTEM FOLLOWING FOOT SURGERY IN (B)(6) 2020, CONTRACTED AN INFECTION. SUBSEQUENTLY, THE PATIENT WAS REPORTED TO HAVE ELEVATED BLOOD PRESSURE AND PASSED AWAY THE SAME DAY. THE CAUSE OF PATIENTS' DEATH IS UNKNOWN. ADDITIONALLY IT IS UNKNOWN WHAT TYPE OF BACTERIA CAUSED THE REPORTED INFECTION.