DUROLANE
Received Feb 18, 2020 · Event occurred Jan 10, 2020
Report MW5093091 · MDR key 9729095
Device
Generic name
Acid, Hyaluronic, Intraarticular
Manufacturer
Bioventus LlcProduct problems
- Patient-Device Incompatibility
Patient
68 YR
- Pain
- Joint Swelling
- Sleep Dysfunction
- Ambulation or Postural Difficulties
- Pain
- Joint Swelling
- Sleep Dysfunction
- Ambulation or Postural Difficulties
Narrative
Description of Event or Problem
SEVERE PAIN, LEG SWELLING. DUROLANE INJECTION GIVEN BILATERAL KNEES ON (B)(6) 2020. SEVERE PAIN AND SWELLING IN QUADRICEPS MUSCLE RESULTED. STILL SEVERE PAIN 5 DAYS LATER. WAS UNABLE TO WALK, GET INTO OR OUT OF BED, GET ON OR OFF TOILET. TRIED ICE, TYLENOL, NAPROXEN WITHOUT RELIEF. PAIN WAS SO SEVERE I COULD NOT SLEEP PAST 2 AM. IT IS NOT INFECTED. THERE IS CURRENTLY NO CALLER OR ERYTHEMA. I HAD DUROLANE INJECTIONS IN THE PAST WITH ONLY A FEW HOURS OF DISCOMFORT AFTERWARD. THIS WAS A WHOLE DIFFERENT ANIMAL. I AM NOW DAY 5 AFTER INJECTIONS AND L KNEE IS ALMOST BACK TO BASELINE, BUT RIGHT STILL WITH SIGNIFICANT PAIN AND BULGE IN QUADRICEPS FOR 14 CM ABOVE PATELLA. I AM A RETIRED PHYSICIAN AND REALIZE THIS IS SIGNIFICANT ENOUGH THAT IT SHOULD BE REPORTED. (B)(6) ADMINISTERED THE PRODUCT AND WOULD HAVE BATCH NUMBER IF NEEDED.