BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNVISC ONE PFS 8MG/ML

    MDR report key: 10501581 · Received September 4, 2020

    Report

    Report Number
    MW5096461
    Event Type
    Malfunction
    Date Received
    September 4, 2020
    Date of Event
    September 3, 2020
    Report Date
    September 3, 2020
    Manufacturer
    GENZYME CORPORATION
    Product Code
    MOZ
    UDI-DI
    58468009003
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Description of Event or Problem · 1

    (B)(6) MED ASST FROM THE DR'S OFFICE CALLED TO SAY THE DOCTOR FOUND A FOREIGN OBJECT FLOATING AROUND IN THE SYNVISC ONE PFS 8MG/ML. THE DOCTOR'S OFFICE SAID IT LOOKS LIKE FIBER FLOATING AROUND IN THE LIQUID. I HAVE PROVIDED THE MANUFACTURER'S TELEPHONE NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    956774 SYNVISC ONE PFS 8MG/ML ACID, HYALURONIC, INTRAARTICULAR MOZ GENZYME CORPORATION UNK 58468009003

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR