inforMED
MalfunctionMOZ

DUROLANE PFS

Received Apr 5, 2024 · Event occurred Nov 7, 2023

Report MW5153612 · MDR key 19059996

Device

Generic name

Acid, Hyaluronic, Intraarticular

Manufacturer

Bioventus Llc

Lot number

21804

Patient

68 YR · Male

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

Narrative

Description of Event or Problem

SPONTANEOUS: MEDICAL ASSISTANT (B)(6) FROM MD OFFICE REPORTS THAT THE GLASS SYRINGE BROKE ON (B)(6) 2023 WHEN DOCTOR TRIED TO GIVE HIS INJECTION AND PT DID NOT GET INJURED, BUT HE DID NOT RECEIVE THE FULL DOSE. UNKNOWN IF THE DEFECTIVE SYRINGE IS AVAILABLE FOR RETURN FOR INSPECTION. UNKNOWN REASON FOR THE SYRINGE BREAKING. UNKNOWN WHY THE PHARMACY WAS NOT NOTIFIED UNTIL NOW. NO ADVERSE EVENT REPORTED. NO FURTHER INFORMATION PROVIDED. INDICATION: UNILATERAL PRIMARY OSTEOARTHRITIS, RIGHT KNEE. REPORTED TO (B)(6) BY HEALTH PROFESSIONAL.