BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEL-ONE

    MDR report key: 3953447 · Received July 10, 2014

    Report

    Report Number
    1822565-2014-00794
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    March 27, 2014
    Report Date
    June 18, 2014
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    (B)(6) 2014 - A MALE PATIENT RECEIVED GEL-ONE INTO BOTH KNEES. (B)(6) 2014 - HE WAS ADMITTED TO THE EMERGENCY ROOM LESS THAN 24 HOURS DUE TO THE SEVERE SWELLING. HE STATED LOWER EXTREMITY FROM KNEES DOWN INCLUDING LEGS AND FEET SWELLED. HE WAS EXPERIENCING SEVERE SWELLING AND POSSIBLE ALLERGIC REACTION. HE WAS PRESCRIBED LASIX QID FOR 14 DAYS. (B)(6) 2014 - NOW, HE HAS TO WEAR COMPRESSION SOCKS AND KEEP LEGS ELEVATED. HE HAS USED SYNVISC FOR THE PAST 5 YEARS AND HAS NEVER HAD THIS REACTION IN THE PAST. REFERENCE MFR REPORT 9612392-2014-00007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403867 GEL-ONE ACID, HYALURONIC, INTRA-ARTICULAR MOZ

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization