inforMED
MalfunctionMOZ

DUROLANE PFS 60MG/3ML

Received Feb 19, 2025

Report MW5166397 · MDR key 21411226

Device

Generic name

Acid, Hyaluronic, Intraarticular

Manufacturer

Bioventus Llc.

Lot number

22737

Patient

NA · Female

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

Narrative

Description of Event or Problem

EXECUTIVE DIRECTOR FROM DOCTORS' OFFICE REPORTS WHEN DOCTOR ATTEMPTED TO INJECT ONE OF THE SYRINGES, THE GEL LEAKED OUT OF THE SYRINGE. THE PT DID NOT RECEIVE THE DOSE AND WILL NEED THE REPLACEMENT. THEY STILL HAVE; MOTHER ONE BUT DID NOT TRY TO INJECT BECAUSE PATIENT WANTED TO GET BOTH INJECTIONS DONE ON THE SAME DAY. THE DEFECTIVE DEVICE IS NOT AVAILABLE FOR RETURN AS IT WAS ALREADY DISPOSED OF. NO ADVERSE EVENT REPORTED. NO FURTHER INFORMATION AVAILABLE. REPORTED TO (B)(6) BY HEALTH PROFESSIONAL.