BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTRYX SYSTEM

    MDR report key: 6673705 · Received June 28, 2017

    Report

    Report Number
    3005099803-2017-01919
    Event Type
    Injury
    Date Received
    June 28, 2017
    Report Date
    April 27, 2017
    Product Code
    OTN
    PMA / PMN Number
    K040787
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ATTACHMENT: [2017-06 EXEMPTION E2013036 SUBMISSION_OTN.XLS]

    Description of Event or Problem · 0

    THE MANUFACTURER REPORT IS BEING SENT AS A REQUIREMENT UNDER SUMMARY REPORTING EXEMPTION APPROVAL NUMBER - E2013036 FOR PRODUCT CODE OTN. SUBMISSIONS FOR PRODUCT CODES OTP AND PAH CAN BE FOUND UNDER MANUFACTURER REPORTS NUMBERS 3005099803-2017-01918 AND 3005099803-2017-01920.

    Additional Manufacturer Narrative · 1

    THIS MANUFACTURER REPORT IS BEING SENT AS A REQUIREMENT UNDER SUMMARY REPORTING EXEMPTION APPROVAL NUMBER ¿ E2013036 FOR PRODUCT CODE OTN. (B)(4).

    Description of Event or Problem · 1

    THE MANUFACTURER REPORT IS BEING SENT AS A REQUIREMENT UNDER SUMMARY REPORTING EXEMPTION APPROVAL NUMBER - E2013036 FOR PRODUCT CODE OTN. SUBMISSIONS FOR PRODUCT CODES OTP AND PAH CAN BE FOUND UNDER MANUFACTURER REPORTS NUMBERS 3005099803-2017-01918 AND 3005099803-2017-01920.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456688 OBTRYX SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR OTN UNK676

    Patients

    Seq Age Sex Outcome Treatment
    1