InjuryLPQ
EXOGEN 4000+ SYSTEM EXPORT
Received May 28, 2013 · Event occurred May 3, 2013
Report 3010203571-2013-00001 · MDR key 3267877
Device
Generic name
Exogen 4000+
Manufacturer
Bioventus LlcModel number
71034150Catalog number
71034150
Lot number
ASKU
Product problems
- Insufficient Device Problem Information
Patient
ASKU
- Pain
- Thrombosis
- Fracture, Arm
Narrative
Description of Event or Problem
ADVERSE EVENT: THROMBOSIS. WHILE USING THE EXOGEN DEVICE TO TREAT A FRACTURE OF THE HUMERUS, THE PT EXPERIENCED PAIN IN HER SHOULDER AND NECK. LATER, SHE WAS DIAGNOSED WITH THROMBOSIS. BIOVENTUS HAVE MADE SEVERAL ATTEMPTS TO COLLECT ADDITIONAL COMPLAINT INFO FROM THE PT AND HOSPITAL, BUT WERE UNSUCCESSFUL.