MAUDE Adverse Event Report: BIOVENTUS LLC. HYALURONIC ACID GEL INJECTION (SODIUM HYALURONATE, STABILIZED (DUROLANE); ACID, HYALURONIC, INTRAARTICULAR

Health Effect - Clinical Codes	Stroke/CVA (1770); Paralysis (1997)
Date of Event	09/19/2024
Type of Reportable Event	Death
Event or Problem Description
(my dad) (b)(6) received bilateral knee hyaluronic acid (ha) injections with durolane on (b)(6) 2024 at 10:14 am at (b)(6) in (b)(6) by dr (b)(6) as he requested.Report (dr notes) state he used a 22g needle and 3 ml sodium hyaluronate, stabilized 60 mg/3m on right and left knees.On (b)(6) 2024 (16 days after injections) at 10:15 pm, (my dad) (b)(6) suffered a massive stroke and was token by ems to (b)(6) hospital in (b)(6) emergency room.The effects of the stroke left him with left side paralyzed; he was unable to regain his speech, swallowing, eyesight or use of left side extremities back.He was taken to hospice and later passed on (b)(6) 2024.My family wanted to make you aware so others would know of the increase numbers of stroke / clots from this medicine.If you need add'l info, please feel free to contact me at (b)(6).Ref report: mw5160916.

• Brand Name: HYALURONIC ACID GEL INJECTION (SODIUM HYALURONATE, STABILIZED (DUROLANE)
• Common Device Name: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): BIOVENTUS LLC.
• MDR Report Key: 20419609
• Report Number: MW5160917
• Device Sequence Number: 7856776
• Product Code: MOZ
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date (Section B): 09/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/09/2024
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ASPIRIN; HYDROCODONE; SOLIFENOCIN ; TRAMADOL
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Male
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White