MalfunctionMOZ

DUROLANE PFS

Received Sep 27, 2024 · Event occurred Sep 9, 2024

Report MW5160285 · MDR key 20335359

Device

Generic name

Acid, Hyaluronic, Intraarticular

Manufacturer

Bioventus Llc.

Lot number

22367

Patient

69 YR · Female

Insufficient Information
Insufficient Information

Narrative

Description of Event or Problem

SPONTANEOUS REPORT. PT STATES WHEN (B)(6) WENT TO INJECT PATIENT'S KNEE ON (B)(6) 2024, (B)(6) WENT TO PUSH PLUNGER, SYRINGE BROKE AND PT WAS UNABLE TO GET SECOND INJECTION (UNKNOWN WHICH KNEE DID NOT GET INJECTED). NO ADVERSE EVENT REPORTED. MISSED DOSE REPORTED. UNKNOWN IF MDO STILL HAS DEFECTIVE DEVICE ON HAND. NO FURTHER INFORMATION PROVIDED. REPORTED TO (B)(6) BY PT/CAREGIVER.