BEUDAMED
    FDA Adverse Event Death Summary report: N

    GEL-ONE

    MDR report key: 7809155 · Received August 23, 2018

    Report

    Report Number
    9612392-2018-00014
    Event Type
    Death
    Date Received
    August 23, 2018
    Date of Event
    July 7, 2018
    Report Date
    July 31, 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 31, 2018 FROM THE FDA MW5078472 DATED JULY 24, 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

    UNK - A PATIENT RECEIVED GEL-ONE. (DATES OF USE: 3 MONTHS) (B)(6) 2018 - THE PATIENT PASSED AWAY. THE CAUSE OF DEATH WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651905 GEL-ONE ACID, HYALURONIC, INTRAARTICULAR MOZ SEIKAGAKU CORPORATION 00-1111-001-00

    Patients

    Seq Age Sex Outcome Treatment
    1 Death