BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC

    MDR report key: 14282559 · Received May 3, 2022

    Report

    Report Number
    MW5109493
    Event Type
    Injury
    Date Received
    May 3, 2022
    Date of Event
    April 26, 2022
    Report Date
    April 29, 2022
    Manufacturer
    GENZYME CORPORATION
    Product Code
    MOZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    RECEIVED SYNVISC IN LEFT KNEE THE MORNING OF (B)(6) 2022. THAT EVENING ENTIRE LEG BEGAN TO SWELL AND NUMBNESS OCCURRED FROM TOES AND PAD LEFT FOOT AND TRAVELED ON LEFT LATERAL ASPECT INTO LEFT HIP. SYMPTOMS CONTINUED TO INTENSIFY. I ALSO EXPERIENCED QUEASY STOMACH, PINS AND NEEDLE SENSATION IN FOOT INTO LEG. ON (B)(6) I WAS NO LONGER ABLE TO WEAR A SHOE ON LEFT FOOT DUE TO SWELLING. EDEMA WAS +2 PITTING EDEMA IN FOOT INTO CALF. I WAS AFEBRILE BUT WAS CONCERNED ABOUT REDNESS ON LEFT LATERAL AND MEDIAL ASPECT OF ANKLE. I WAS UNABLE TO STAND ON LEFT LEG DUE TO PAIN AND AWAKENED SEVERAL TIMES DURING THE NIGHT DUE TO PAIN. I WAS UNABLE TO REACH PROVIDER WHO INJECTED SYNVISC, THEREFORE SCHEDULED APPOINTMENT WITH PA AT PCP OFFICE. A NURSE FROM ORTHOPEDIC PROVIDER CALLED AFTERWARDS. I EXPLAINED SYMPTOMS TO HIM AND TOLD HIM I HAD SCHEDULED PA APPOINTMENT. PA WAS UNFAMILIAR WITH SYNVISC. SHE WRAPPED ACE WRAP AROUND FOOT AND LEG, ADVISED ELEVATING AND ICING LEG. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1378959 SYNVISC ACID, HYALURONIC, INTRAARTICULAR MOZ GENZYME CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other