BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEL-ONE

    MDR report key: 4291263 · Received October 27, 2014

    Report

    Report Number
    1822565-2014-01370
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    July 29, 2014
    Report Date
    September 29, 2014
    Manufacturer
    SEIKAGAKU CORP.
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014 - A (B)(6) YEARS OLD MALE PT RECEIVED A SINGLE SHOT GEL-ONE. ON (B)(6) 2014- THE PT WAS EXPERIENCING REDNESS, SWELLING, AND ITCHINESS. THE AMOUNT OF SWELLING AND PAIN, THE PT WAS SUFFERING, WAS MOST CONCERNING TO THE DR UNK - THE DR PRESCRIBED NSAIDS AND ICE FOR INFLAMMATION AND SWELLING. UNK - THE PT IMPROVED SLOWLY OVER A COURSE OF THREE WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684027 GEL-ONE ACID, HYALURONIC, INTRAARTICULAR MOZ SEIKAGAKU CORP. 0013F05G

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other