BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTAGE FIT SYSTEM

    MDR report key: 4740930 · Received April 30, 2015

    Report

    Report Number
    3005099803-2015-01219
    Event Type
    Injury
    Date Received
    April 30, 2015
    Report Date
    February 10, 2015
    Product Code
    OTN
    PMA / PMN Number
    K020110
    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. 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. PLEASE SEE ATTACHED SPREADSHEET FOR THE BIMONTHLY SUBMISSION DUE APRIL 30, 2015. SUBMISSIONS FOR PRODUCT CODES PAH AND OTP CAN BE FOUND UNDER MANUFACTURER REPORTS NUMBERS 3005099803-2015-01218 AND 3005099803-2015-01220.

    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 PAH AND OTP CAN BE FOUND UNDER MANUFACTURER REPORTS NUMBERS 3005099803-2015-01218 AND 3005099803-2015-01220.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284735 ADVANTAGE FIT SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR OTN M0068502110

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown