BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLYX

    MDR report key: 3882958 · Received May 29, 2014

    Report

    Report Number
    3882958
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    February 21, 2014
    Report Date
    May 29, 2014
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    OTN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316743 SOLYX MESH, SURGICAL, GYNECOLOGIC OTN BOSTON SCIENTIFIC UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR