BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTRYX SYSTEM

    MDR report key: 4214690 · Received October 30, 2014

    Report

    Report Number
    3005099803-2014-03551
    Event Type
    Injury
    Date Received
    October 30, 2014
    Report Date
    August 29, 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. PLEASE SEE ATTACHED FOR SUPPLEMENT SUBMISSION DUE (B)(4) 2015.

    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 3005099803-2014-03549 AND 3005099803-2014-03550.

    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 3005099803-2014-03549 AND 3005099803-2014-03550.

    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 3005099803-2014-03549 AND 3005099803-2014-03550.

    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. PLEASE SEE ATTACHED SPREADSHEET FOR THE BIMONTHLY SUBMISSION DUE OCTOBER 31, 2014. SUBMISSIONS FOR PRODUCT CODES OTP AND PAH CAN BE FOUND UNDER MANUFACTURER REPORTS NUMBERS 3005099803-2014-03549 AND 3005099803-2014-03550.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694949 OBTRYX SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR OTN UNK676

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown