BEUDAMED
    FDA Adverse Event Death Summary report: N

    HYALURONIC ACID GEL INJECTION (SODIUM HYALURONATE, STABILIZED (DUROLANE)

    MDR report key: 20419609 · Received October 9, 2024

    Report

    Report Number
    MW5160917
    Event Type
    Death
    Date Received
    October 9, 2024
    Date of Event
    September 19, 2024
    Report Date
    September 29, 2024
    Manufacturer
    BIOVENTUS LLC.
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    (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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313379 HYALURONIC ACID GEL INJECTION (SODIUM HYALURONATE, STABILIZED (DUROLANE) ACID, HYALURONIC, INTRAARTICULAR MOZ BIOVENTUS LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Male Death ASPIRIN| HYDROCODONE| SOLIFENOCIN | TRAMADOL