BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC HYLAN G-F-20

    MDR report key: 343161 · Received July 23, 2001

    Report

    Report Number
    MW1022430
    Event Type
    Injury
    Date Received
    July 23, 2001
    Date of Event
    May 1, 2001
    Report Date
    July 23, 2001
    Manufacturer
    BIOMATRIX, INC. WYETH AYERST LABORATORIES
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR HAD 3 SHOTS OF PRODUCT. IN ABOUT 2 WEEKS RPTR BEGAN TO EXPERIENCE WEAKNESS OF MUSCLES AND JOINTS. THE PRODUCT WAS INJECTED IN THE RIGHT KNEE. RPTR ALSO HAS NUMBNESS OF FINGERS WHICH AWAKENS THEM UP AT NIGHT MULTIPLE TIMES. ALSO FEELS A SENSATION OF STICKING NEEDLES IN THEIR FINGERS AT NIGHT. RPTR ALSO IS HAVING TROUBLE GETTING OUT OF BED AND FEELS CRIPPLED. DR TOLD RPTR THEY WERE THE FIRST PT THAT HAD A REACTION. RPTR HAS HAD TO HAVE MORE STEROIDS SINCE INJECTION OF PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33112 SYNVISC HYLAN G-F-20 HYLAN MOZ BIOMATRIX, INC. WYETH AYERST LABORATORIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Life Threatening| R