BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTAGE SYSTEM

    MDR report key: 4042226 · Received August 27, 2014

    Report

    Report Number
    3005099803-2014-02934
    Event Type
    Injury
    Date Received
    August 27, 2014
    Report Date
    July 1, 2014
    Product Code
    OTN
    PMA / PMN Number
    K020110
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MANUFACTURER REPORT IS BEING SENT AS A REQUIREMENT UNDER SUMMARY REPORTING EXEMPTION APPROVAL NUMBER ¿ (B)(4) FOR PRODUCT CODE OTN.

    Description of Event or Problem · 1

    THIS MANUFACTURER REPORT IS BEING SENT AS A REQUIREMENT UNDER SUMMARY REPORTING EXEMPTION APPROVAL NUMBER (B)(4) FOR PRODUCT CODE OTN. SUBMISSIONS FOR PRODUCT CODES OTP AND PAH CAN BE FOUND UNDER MANUFACTURER REPORTS NUMBERS 3005099803-2014-02932 AND 3005099803-2014-02933.

    Description of Event or Problem · 1

    THIS MANUFACTURER REPORT IS BEING SENT AS A REQUIREMENT UNDER SUMMARY REPORTING EXEMPTION APPROVAL NUMBER ¿ (B)(4) FOR PRODUCT CODE OTN. SUBMISSIONS FOR PRODUCT CODES OTP AND PAH CAN BE FOUND UNDER MANUFACTURER REPORT NUMBERS 3005099803-2014-02932 AND 3005099803-2014-02933.

    Description of Event or Problem · 1

    THIS MANUFACTURER REPORT IS BEING SENT AS A REQUIREMENT UNDER SUMMARY REPORTING EXEMPTION APPROVAL NUMBER (B)(4) FOR PRODUCT CODE OTN. SUBMISSIONS FOR PRODUCT CODES OTP AND PAH CAN BE FOUND UNDER MANUFACTURER REPORTS NUMBERS 3005099803-2014-02932 AND 3005099803-2014-02933.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521905 ADVANTAGE SYSTEM MESH, SURGICAL, POLYMERIC OTN UNK557

    Patients

    Seq Age Sex Outcome Treatment
    1