DUROLANE PFS

Description of Event or Problem

DATE OF MALFUNCTION IS (B)(6) 2024. PRACTICE MANAGER REPORTED WHEN THE NURSE WENT TO DO THE INJECTION ON THE PATIENT THAT PART OF THE VIAL BROKE OFF. PRACTICE MANAGER STATED THE PATIENT RECEIVED A DOSE IN ONE KNEE BUT NOT IN THE OTHER KNEE. PATIENT DID NOT MISS A DOSE AND NO ADVERSE EVENT REPORTED. UNKNOWN IF DEFECTIVE DEVICE IS ON HAND FOR RETURN. NO FURTHER INFORMATION PROVIDED. FREQUENCY: INJECT 1 SYRINGE INTRA-ARTICULARLY TO BILATERAL KNEES ONE TIME AT THE PHYSICIAN'S OFFICE. INDICATION: UNILATERAL PRIMARY OSTEOARTHRITIS, LEFT KNEE. REPORTED TO (B)(6) BY: HEALTH PROFESSIONAL.