BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEL-ONE

    MDR report key: 8636118 · Received May 23, 2019

    Report

    Report Number
    9612392-2019-00007
    Event Type
    Injury
    Date Received
    May 23, 2019
    Date of Event
    January 28, 2019
    Report Date
    May 3, 2019
    Manufacturer
    SEIKAGAKU CORPORATION
    Product Code
    MOZ
    UDI-DI
    H131001111001001
    PMA / PMN Number
    P080020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A DEFINITIVE REPORT. THIS CASE IS RECEIVED BY SEIKAGAKU CORPORATION ON MAY 3, 2019 FROM THE FDA AS MW5086034 DATED APRIL 26, 2019. ACCORDING TO THE RESULT OF INVESTIGATION, THERE WERE NO DEVIATIONS OR OUT-OF-SPECIFICATIONS FOUND IN THE MANUFACTURING PROCESS, THE IN-PROCESS TESTING, THE RELEASE TESTING, AND THE ENVIRONMENTAL MONITORING FOR LOT# 0017Z20G. 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 PATIENT REPORTED BEING HOSPITALIZED WITH TINGLING AND PAIN THROUGH ENTIRE BODY. THE ONSET DATE WAS (B)(6) 2019. ACCORDING TO THE REPORTER, THE PATIENT RECEIVED GEL-ONE INTRA-ARTICULARLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431411 GEL-ONE ACID, HYALURONIC, INTRAARTICULAR MOZ SEIKAGAKU CORPORATION 00-1111-001-00 0017Z20G H131001111001001

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization