inforMED
MalfunctionMOZ

DUROLANE PFS

Received May 24, 2024 · Event occurred May 16, 2024

Report MW5155405 · MDR key 19405703

Device

Generic name

Acid, Hyaluronic, Intraarticular

Manufacturer

Bioventus Llc

Lot number

22138

Patient

Male

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

Narrative

Description of Event or Problem

SPONTANEOUS CALL FROM PENA C REFERRAL COORDINATOR AT DOCTOR OFFICE STATING MEDICATION CAME OUT OF THE SIDE OF THE SYRINGE (DEFECTIVE SYRINGE). MISSED DOSE. NO ADVERSE EVENT REPORTED. UNKNOWN IF PATIENT STILL HAS DEFECTIVE DEVICE ON HAND FOR RETURN. UNKNOWN IF MD IS AWARE. NO FURTHER INFORMATION PROVIDED. DATE OF MALFUNCTION: (B)(6) 2024. REPORTED TO (B)(6) BY: HEALTH PROFESSIONAL.