BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOVISC INJ 88MG/4ML

    MDR report key: 7037483 · Received November 15, 2017

    Report

    Report Number
    MW5073386
    Event Type
    Injury
    Date Received
    November 15, 2017
    Date of Event
    November 13, 2017
    Report Date
    November 14, 2017
    Manufacturer
    UNK
    Product Code
    MOZ
    UDI-DI
    59676082001
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT INJECTED WITH MONOVISC YESTERDAY AND COMPLAINS OF SWELLING, TIGHTNESS, AND STIFFNESS ABOVE THE KNEE INJECTED. SHE REPORTS NO PAIN, ITCHING, REDNESS, OR WARMTH IN THE AREA. TOLD HER THAT SHE MAY BE JUST EXPERIENCING SOME OF THE EDEMA AND SWELLING ASSOCIATED WITH THE INJECTION. ADVISED HER SHE CA ICE IT OR SOAK IT TO LOOSEN UP BUT EVENTUALLY, KNEE SHOULD RETURN TO NORMAL STATE. IF IT DOESN'T OR IF IT GETS WORSE, CALL MD OFFICE. IS THE PRODUCT COMPOUNDED: NO. IS THE PRODUCT OVER-THE-COUNTER: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814645 MONOVISC INJ 88MG/4ML ACID, HYALURONIC, INTRAARTICULAR MOZ UNK 59676082001

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR