inforMED
MalfunctionMOZ

DUROLANE

Received Nov 21, 2023

Report MW5148363 · MDR key 18191818

Device

Generic name

Acid, Hyaluronic, Intraarticular

Manufacturer

Bioventus Llc.

Lot number

21478

Patient

Male

  • Insufficient Information
  • Insufficient Information

Narrative

Description of Event or Problem

SPONTANEOUS REPORT. NURSE AT DOCTOR OFFICE REPORTED THAT DUROLANE SYRINGE WAS DEFECTIVE. SHE REPORTED THAT THE TIP OF THE SYRINGE BURST WHEN EXAMINING MEDICATION. MISSED DOSE, UNKNOWN IF PT EXPERIENCED ANY ADVERSE EVENTS. DEVICE NOT AVAILABLE. INDICATION: UNILATERAL PRIMARY OSTEOARTHRITIS, LEFT KNEE. REPORTED TO (B)(6) BY HEALTH PROFESSIONAL.