EXOGEN ULTRASOUND BONE HEALING SYSTEM
Received Oct 8, 2021 · Event occurred Jul 1, 2020
Report 3010203571-2021-00011 · MDR key 12599554
Device
Generic name
Exogen
Manufacturer
Bioventus LlcModel number
71034400Catalog number
71034400
Lot number
20FM16498
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
47 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 AFTER ANKLE SURGERY, EXPERIENCED CONTINUOUS PAIN AND AN INFECTION. THE PATIENT BEGAN USING THE DEVICE IN JULY OF 2020, AFTER AN UNKNOWN DURATION THE PATIENT WAS PLACED ON A PICC LINE AND AN AGGRESSIVE TREATMENT OF ANTIBIOTICS. THE PATIENT REPORTS THEY DO NOT HAVE FULL FUNCTION OF THEIR FOOT AS A RESULT OF THE INFECTION. IT IS UNKNOWN THE TYPE OF BACTERIA THAT CAUSED THE INFECTION.