BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEL-ONE

    MDR report key: 7745087 · Received August 2, 2018

    Report

    Report Number
    9612392-2018-00012
    Event Type
    Injury
    Date Received
    August 2, 2018
    Report Date
    July 10, 2018
    Manufacturer
    SEIKAGAKU CORPORATION
    Product Code
    MOZ
    PMA / PMN Number
    P080020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A DEFINITIVE REPORT. THIS CASE IS RECEIVED BY SEIKAGAKU CORPORATION ON JULY 10, 2018 FROM THE FDA MW5078158 DATED JULY 3, 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

    A FEMALE PATIENT WHO RECEIVED GEL-ONE INJECTION IN THE KNEE. THE PATIENT HAD A KNEE SURGERY. EVENT OUTCOME WAS REPORTED AS "HOSPITALIZATION" BY THE REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586936 GEL-ONE ACID, HYALURONIC, INTRAARTICULAR MOZ SEIKAGAKU CORPORATION 00-1111-001-00

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization