DUROLANE-HA (HYALURONIC ACID)
Received Feb 25, 2025 · Event occurred Jan 7, 2025
Report MW5166774 · MDR key 21459072
Device
Patient
85 YR · Unknown
- Necrosis
- Rash
- Injection Site Reaction
- Necrosis
- Rash
- Injection Site Reaction
Narrative
Description of Event or Problem
PATIENT RECEIVED STANDARD DUROLANE-HA (HYALURONIC ACID) (LOT #22591) INJECTION WITH 2ML OF KENALOG IN BOTH KNEES ON (B)(6) 2025. THE LEFT KNEE SUBSEQUENTLY DEVELOPED AN ADVERSE SKIN REACTION/RASH AND SKIN NECROSIS AT THE INJECTION SITE. THE RIGHT KNEE DID NOT HAVE ANY COMPLICATIONS. HE WAS SEEN IN OUR OFFICE ON (B)(6) AND ALSO (B)(6) TO MONITOR. WE PERFORMED LAB TESTING AND MONITORED FOR UNDERLYING INFECTION. HE WAS LATER HOSPITALIZED FOR CARDIAC COMPLICATIONS AND WOUND MONITORING. THERE ARE PUBLISHED CASE REPORTS OF LIVIDO RETICULARIS AND SKIN NECROSIS AFTER DUROLANE INJECTIONS AND OTHER HYALURONIC ACID INJECTIONS. I HAVE REACHED OUT TO THE MEDICAL DIRECTOR OF BIOVENTUS AND THE COMPANY TO DISCUSS FURTHER. PATIENT WILL BE RE-EVALUATED TODAY ((B)(6) 2025).