BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTRYX SYSTEM

    MDR report key: 3897132 · Received June 26, 2014

    Report

    Report Number
    3005099803-2014-02412
    Event Type
    Injury
    Date Received
    June 26, 2014
    Report Date
    April 25, 2014
    Product Code
    OTN
    PMA / PMN Number
    K040787
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    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.

    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.

    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 3005099803-2014-02411 AND 3005099803-2014-02415.

    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 3005099803-2014-02411 AND 3005099803-2014-02415.

    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 3005099803-2014-02411 AND 3005099803-2014-02415.

    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 3005099803-2014-02411 AND 3005099803-2014-02415.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375236 OBTRYX SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR OTN M0068504000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown