BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNVISC

    MDR report key: 23414908 · Received October 29, 2025

    Report

    Report Number
    MW5178174
    Event Type
    Malfunction
    Date Received
    October 29, 2025
    Date of Event
    February 26, 2024
    Report Date
    October 28, 2025
    Manufacturer
    GENZYME CORPORATION
    Product Code
    MOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT REPORTED SHE HAD SYNVISC SHOT TO HER RIGHT LEG ON (B)(6) 2024. A WEEK LATER, SHE HAD THE SHOT IN HER LEFT LEG. SHE HAD AN ADVERSE REACTION TO THE SHOT CAUSING SEVERE PAIN, SWELLING AND A COMPLETE SHUTDOWN OF HER BODY WHEN SHE GOES TO BED. PATIENT STATED SHE HAD BEEN USING THIS SHOT FOR OVER 8 YEARS AND THIS IS THE FIRST TIME THIS HAS HAPPENED. SHE CONTACTED HER DOCTOR BUT COULD NOT GET AN ACCURATE RESPONSE. AS OF NOW HER PAIN IS SO BAD SHE CAN BARELY MOVE. PT CODES: 1994, 4577. DEVICE CODE: 4001. REF REPORT: MW5178175.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1618761 SYNVISC ACID, HYALURONIC, INTRAARTICULAR MOZ GENZYME CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other