InjuryMOZ
GELSYN-3
Received May 13, 2022 · Event occurred Apr 19, 2022
Report MW5109714 · MDR key 14408904
Device
Generic name
Acid, Hyaluronic, Intraarticular
Manufacturer
Bioventus Llc. / Ibsa Farmaceutici Italia SrlProduct problems
- Adverse Event Without Identified Device or Use Problem
Patient
75 YR · Female
- Pain
- Joint Laxity
- Pain
- Joint Laxity
Narrative
Description of Event or Problem
GELSYN-3 --3 INJECTIONS 1 WEEK APART. LAST INJECTION ON (B)(6) 2022. KNEE IS MORE PAINFUL AND MORE UNSTABLE THAN BEFORE THE INJECTIONS. THE PRACTITIONER EXPLAINED THAT 3 INJECTIONS ARE REQUIRED NO MATER THE SIZE OF THE KNEE, I.E., A 250 POUND PERSON GETS THE SAME AMOUNT OF FLUID AS A 100 POUND PERSON. THE PRACTITIONER EXPLAINED THAT THERE IS PROBABLY TOO MUCH FLUID ON THE KNEE AND THE ONLY SOLUTION IS A CORTISONE INJECTION TO CALM IT DOWN. I AM VERY DISSATISFIED WITH THIS PRODUCT AND THE FACT THAT IT CANNOT BE GAUGED TO SUIT MY CIRCUMSTANCES.