MalfunctionMOZ

DUROLANE PFS

Received Apr 29, 2024 · Event occurred Apr 25, 2024

Report MW5154428 · MDR key 19212631

Device

Generic name

Acid, Hyaluronic, Intraarticular

Manufacturer

Bioventus Llc

Patient

61 YR · Male

Insufficient Information
Insufficient Information

Narrative

Description of Event or Problem

SPONTANEOUS REPORT. INSURANCE VERIFICATION REPRESENTATIVE AT MDO REPORTED THAT THE DUROLANE MEDICATION LEAKED OUT OF THE PEN, THERE WAS NO SEAL OR THE SEAL WAS BAD. UNKNOWN IF PT MISSED DOSE, IF PT CURRENTLY POSSESSES DEFECTIVE DEVICE OR IF ADVERSE EVENT OCCURRED. NO FURTHER INFORMATION PROVIDED. REPORTED TO (B)(6) BY: HEALTH PROFESSIONAL.