DUROLANE
Received Jul 19, 2019 · Event occurred Jul 9, 2019
Report MW5088262 · MDR key 8811412
Device
Generic name
Acid, Hyluronic, Intraarticular
Manufacturer
Bioventus LlcProduct problems
- Adverse Event Without Identified Device or Use Problem
Patient
47 YR
- Pain
- Swelling
- Vomiting
- Sweating
- Ambulation or Postural Difficulties
- Pain
- Swelling
- Vomiting
- Sweating
- Ambulation or Postural Difficulties
Narrative
Description of Event or Problem
ON (B)(6) 2019 I HAD DUROLANE INJECTIONS IN BOTH OF KNEES FOR OSTEOARTHRITIS. I'VE NEVER HAD ANY FOOD OR MED ALLERGIES TO ANYTHING PREVIOUSLY. THE ONLY MEDICATION I WAS ON AT THE TIME WAS 50 MG TRAMADOL FOR PAIN. I HAD PREVIOUSLY HAD CORTISONE INJECTIONS WITH NO SIDE EFFECTS. THE INJECTIONS WERE AT 4 PM, BY MIDNIGHT, I WAS IN EXTREME PAIN AND IT WAS VERY DIFFICULT TO WALK TO THE NEXT ROOM IN MY HOME JUST TO USE THE BATHROOM. AT 3:30 AM I WOKE UP IN EXCRUCIATING PAIN, SWEATING, PUKING, AND HAD NO USE OF MY LEGS AT ALL. I COULD NOT BEND OR LIFT THEM ON MY OWN. MY HUSBAND TOOK ME TO THE ER WHERE THEY COULD DO NOTHING FOR ME BUT ADMINISTER FLUIDS AND PAIN MEDS. I COULD NOT WALK AGAIN UNTIL (B)(6) 2019 (3+ DAYS LATER) AND THEN I COULD ONLY WALK ASSISTED BY A WALKER. IT'S NOW (B)(6) 2019, 9 DAYS AFTER INJECTIONS, AND MY LEGS ARE STILL SWOLLEN, IN EXTREME PAIN, AND I STILL CANNOT WALK NORMAL WITH MY LEFT LEG. I AM UNABLE TO CLIMB ANY STEPS / STAIRS. I HAVE BEEN GOING TO PHYSICAL THERAPY, BUT MY LEFT LEG IS NOT IMPROVING. DID THE PROBLEM STOP AFTER THE PERSON REDUCED THE DOSE OR STOPPED TAKING OR USING THE PRODUCT? NO; DID THE PROBLEM RETURN IF THE PERSON STARTED TAKING OR USING THE PRODUCT AGAIN? DOESN'T APPLY.