inforMED
InjuryMOZ

DUROLANE PFS

Received Dec 16, 2021

Report MW5106147 · MDR key 13026194

Device

Generic name

Acid, Hyaluronic, Intraarticular

Manufacturer

Bioventus Llc

Product problems

  • Adverse Event Without Identified Device or Use Problem

Patient

Female

  • Hypersensitivity/Allergic reaction
  • Hypersensitivity/Allergic reaction

Narrative

Description of Event or Problem

PATIENT HAD INFLAMMATORY REACTION (HAD AN ADVERSE REACTION TO DUROLANE) MD IS SWITCHING PATIENT TO EUFLEXXA, NO MORE INFORMATION DIRECTIONS; INJECT ONE SYRINGE INTRA-PARTICULARLY TO BILATERAL KNEES ONE TIME AT THE PHYSICIAN¿S OFFICE. INDICATION: BILATERAL PRIMARY OSTEOARTHRITIS OF KNEE. REPORTED TO (B)(6)/CAREMARK BY: PATIENT/CAREGIVER.