SODIUM HYALURONATE (DUROLANE) 60 MG/3ML
Received Mar 29, 2021 · Event occurred Feb 12, 2021
Report MW5100356 · MDR key 11588416
Device
Product problems
- Therapeutic or Diagnostic Output Failure
Patient
Not reported
- Pain
- Inadequate Pain Relief
- Pain
- Inadequate Pain Relief
Narrative
Description of Event or Problem
TWO PTS (ONE MALE, ONE FEMALE) HAD SIMILAR REACTIONS TO DUROLANE VISCOSUPPLEMENTATION INJECTION THAT WERE UNEXPECTED AND UNCOMMON. PATIENT #1 RECEIVED 60 MG SODIUM HYALURONATE INJECTION IN RIGHT KNEE ON (B)(6) 2021. PATIENT RETURNED TO CLINIC ON (B)(6) REPORTING WORSENING PAIN SINCE INJECTION. PATIENT #2 RECEIVED 60 MG SODIUM HYALURONATE INJECTION IN EACH KNEE ALSO ON (B)(6). PATIENT RETURNED TO CLINIC ON (B)(6) WITH 0 MINUTES OF RELIEF SINCE LAST INJECTION AND NO IMPROVEMENT IN SYMPTOMS. APPEARS MEDICATIONS WERE FROM THE SAME LOT. SUSPECT POSSIBLE DEVICE MALFUNCTION DUE TO UNEXPECTED ABSENCE OF RELIEF FROM SYMPTOMS FOR ALL THREE INJECTIONS FROM SAME LOT.