BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYLAN G-F20 48MG/6ML INJ,SYRINGE,6ML

    MDR report key: 22197708 · Received June 12, 2025

    Report

    Report Number
    MW5171448
    Event Type
    Injury
    Date Received
    June 12, 2025
    Date of Event
    May 21, 2025
    Report Date
    June 6, 2025
    Manufacturer
    SANOFI / GENZYME CORPORATION
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    (B)(4) ---ARTHRALGIA^ (B)(4) ---ADVERSE DRUG REACTION NOS. 60-YEAR-OLD FEMALE PATIENT RECEIVING SYNVISC INJECTIONS SINCE (B)(6) 2024 (TWENTY-TWENTY-FOUR) RECEIVED BILATERAL INJECTIONS ON (B)(6) 2025. LEFT KNEE WAS LOT EFRSLB03 EXP. 7/2027, RIGHT KNEE WAS FRSLB04 EXP. 12/2027. INJECTIONS RECEIVED (B)(6) 2025 @14:00. THE NEXT MORNING, (B)(6) 2025 AT ~09:00 PATIENT CALLED IN TO ORTHO CLINIC TO REPORT SEVERE RIGHT KNEE PAIN, REQUIRING HER TO USE A CANE. SHE WAS ADVISED TO ICE, ELEVATE, REST, TAKE ACETAMINOPHEN AND A PRESCRIPTION FOR A PREDNISONE TAPER WAS ORDERED. NOTE, LEFT KNEE, FINE, NO ISSUES (DIFFERENT LOT#).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1008246 HYLAN G-F20 48MG/6ML INJ,SYRINGE,6ML ACID, HYALURONIC, INTRAARTICULAR MOZ SANOFI / GENZYME CORPORATION FRSLB04

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female