BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEL-ONE

    MDR report key: 7612544 · Received June 18, 2018

    Report

    Report Number
    9612392-2018-00010
    Event Type
    Injury
    Date Received
    June 18, 2018
    Report Date
    May 22, 2018
    Manufacturer
    SEIKAGAKU CORPORATION
    Product Code
    MOZ
    PMA / PMN Number
    P080020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    METHOD CODE WERE UPDATED. THE UPDATED INFORMATION WAS RECEIVED BY ZIMMER BIOMET ON AUGUST 22, 2018 FROM THE PATIENT. EVENT WAS CORRECTED. THE INITIAL INFORMATION RECEIVED FROM THE PATIENT ON (B)(6) WAS THE INJECTION IN THE LEFT AND RIGHT KNEE BUT NOT CLARIFIED WHICH KNEE WAS AFFECTED. SEIKAGAKU CORPORATION IS ALSO SUBMITTING THIS REPORT ON BEHALF OF ZIMMER, INC. AS THE IMPORTER WITH AUTHORIZATION BY THE EXEMPTION NUMBER E2011015.

    Additional Manufacturer Narrative · 0

    THIS CASE IS RECEIVED BY SEIKAGAKU CORPORATION ON MAY 30, 2018. SEIKAGAKU CORPORATION IS ALSO SUBMITTING THIS REPORT ON BEHALF OF ZIMMER, INC. AS THE IMPORTER WITH AUTHORIZATION BY THE EXEMPTION NUMBER E2011015.

    Description of Event or Problem · 0

    ON (B)(6) 2018- AN 85 YEAR-OLD MALE PATIENT UNDERWENT GEL-ONE INJECTION INTO BILATERAL KNEES AND EXPERIENCED PAIN, SWELLING AND RED SPLOTCHES FROM BOTH RIGHT AND LEFT KNEES.

    Description of Event or Problem · 0

    ON (B)(6) 2018 - AN (B)(6) MALE PATIENT UNDERWENT GEL-ONE INJECTION AND EXPERIENCED PAIN, SWELLING AND RED SPLOTCHES FROM THE KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453248 GEL-ONE ACID, HYALURONIC, INTRAARTICULAR MOZ SEIKAGAKU CORPORATION 00-1111-001-00

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other