BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEL-ONE

    MDR report key: 7726479 · Received July 27, 2018

    Report

    Report Number
    9612392-2018-00011
    Event Type
    Injury
    Date Received
    July 27, 2018
    Date of Event
    June 17, 2018
    Report Date
    July 2, 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

    THIS IS A DEFINITIVE REPORT. THIS CASE IS RECEIVED BY SEIKAGAKU CORPORATION ON JULY 2, 2018 FROM THE FDA MW5078007 DATED JUNE 26, 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 - A FEMALE PATIENT WHO RECEIVED GEL-ONE INJECTION IN THE LEFT KNEE ON UNKNOWN DATE FELL AND BLACKED OUT. ON (B)(6) 2018 - THE PATIENT WENT TO ER AND WAS TREATED. EVENT OUTCOME WAS REPORTED AS "HOSPITALIZATION" BY THE REPORTER, "OTHER HEALTH PROFESSIONAL". ON (B)(6) 2018 - THE EVENT WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568459 GEL-ONE ACID, HYALURONIC, INTRAARTICULAR MOZ SEIKAGAKU CORPORATION 00-1111-001-00

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization