inforMED
InjuryMOZ

DUROLANE PFS

Received Jun 25, 2019 · Event occurred Apr 1, 2019

Report MW5087634 · MDR key 8735532

Device

Generic name

Acid, Hyaluronic, Intraarticular

Manufacturer

Bioventus Llc

Product problems

  • Therapeutic or Diagnostic Output Failure

Patient

80 YR

  • Pain
  • Therapeutic Response, Decreased
  • Pain
  • Therapeutic Response, Decreased

Narrative

Description of Event or Problem

RECEIVED SPONTANEOUS CALL FROM PATIENT REPORTING THAT THE DUROLANE IS NOT WORKING AND SHE IS IN CONSTANT PAIN, WHICH IS AFFECTING HER QUALITY OF LIFE. PATIENT STATES THAT SYNVISC WORKED PERFECTLY AND SHE WILL LIKE TO GO BACK TO SYNVISC. NO OTHER INFORMATION KNOWN. REPORTED TO (B)(6) BY: PATIENT/CAREGIVER.