inforMED
MalfunctionMOZ

DUROLANE PFS 60MG/3ML

Received Sep 27, 2024 · Event occurred Jul 6, 2024

Report MW5160310 · MDR key 20336007

Device

Generic name

Acid, Hyaluronic, Intraarticular

Manufacturer

Bioventus Llc.

Lot number

22210

Patient

54 YR · Female

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

Narrative

Description of Event or Problem

SPONTANEOUS REPORT. PHYSICIAN REPORTED A DEFECTIVE DEVICE. LOCK WAS DEFECTIVE AND NEEDLE FAILED TO ATTACH; "-1.5ML" OF MEDICATION WAS NOT INJECTED. NO ADVERSE EVENT WAS REPORTED. UNKNOWN IF DEFECTIVE DEVICE IS AVAILABLE FOR RETURN. REPORTED TO (B)(6) BY HEALTH PROFESSIONAL.