BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 22196336 · Received June 12, 2025

    Report

    Report Number
    MW5171413
    Event Type
    Injury
    Date Received
    June 12, 2025
    Date of Event
    May 15, 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

    EVENT: (B)(4) ---ARTHRALGIA^ (B)(4) ---JOINT PAIN^ (B)(4) ---PAIN IN CALF 49 Y/O PATIENT RECEIVING SYNVISC INJECTIONS SINCE AT LEAST 2022 RECEIVED BILATERAL KNEE INJECTIONS OF SYNVISC ONE ON (B)(6) 2025 AT 08:59. LOT#FRSLB04 EXP:12/2027 IN BOTH KNEES. PATIENT RETURNED TO OUR ED 12-14 HOURS LATER WITH BILATERAL KNEE PAIN AND CALF SWELLING. PATIENT TREATED WITH HYDROCODONE AT THE ED. FOLLOW-UP IN ORTHO CLINIC (B)(6) 2025 WHERE PATIENT REPORTED LOW-GRADE FEVER. JOINTS ASPIRATED (NO CONCERNING FINDINGS). ORTHO ADDED 5 DAY STEROID BURST. REF REPORT: MW5171412.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552176 HYLAN G-F20 48MG/6ML INJ, SYRINGE, 6ML ACID, HYALURONIC, INTRAARTICULAR MOZ SANOFI / GENZYME CORPORATION FRSLB04

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female