BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIRITE SYRINGE

    MDR report key: 8745254 · Received June 28, 2019

    Report

    Report Number
    2431014-2019-00000
    Event Type
    Malfunction
    Date Received
    June 28, 2019
    Report Date
    June 27, 2019
    Manufacturer
    DYNAREX CORPORATION
    Product Code
    FMF
    UDI-DI
    00616784698526
    PMA / PMN Number
    K132553
    Removal / Correction Number
    MW5087168
    Product Problem
    Yes
    Report Source
    Manufacturer report

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536692 EPIRITE SYRINGE PISTON SYRINGE FMF DYNAREX CORPORATION 6985 UNKNOWN 00616784698526

    Patients

    Seq Age Sex Outcome Treatment
    1