inforMED
MalfunctionMOZ

DUROLANE PFS

Received Sep 30, 2024

Report MW5160418 · MDR key 20346452

Device

Generic name

Acid, Hyaluronic, Intraarticular

Manufacturer

Bioventus Llc.

Lot number

22399

Patient

NA · Female

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

INDICATION -PAIN IN RIGHT KNEE, UNILATERAL PRIMARY OSTEOARTHRITIS, RIGHT KNEE, UNILATERAL PRIMARY OSTEOARTHRITIS, LEFT KNEE SPONTANEOUS CALL FROM (B)(6). FROM (B)(6) OFFICE TO REPORT DEFECTIVE DEVICE - NO PLUNGER IN SYRINGE SO INJECTION CAN'T BE USED. UNK IF PT MISSED A DOSE. NO ADVERSE EVENT REPORTED. UNKNOWN IF MD OFFICE HAS DEVICE ON HAND FOR RETURN. NO FURTHER INFORMATION PROVIDED. REPORTED TO (B)(6) BY HEALTH PROFESSIONAL.