BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE PELVIC FLOOR REPAIR KITS

    MDR report key: 3897147 · Received June 26, 2014

    Report

    Report Number
    3005099803-2014-02411
    Event Type
    Injury
    Date Received
    June 26, 2014
    Report Date
    April 30, 2014
    Product Code
    OTP
    PMA / PMN Number
    K071957
    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 OTP.

    Additional Manufacturer Narrative · 1

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

    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 OTP. SUBMISSIONS FOR PRODUCT CODES OTN AND PAH CAN BE FOUND UNDER MANUFACTURER REPORTS NUMBERS 3005099803-2014-02412 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 OTP. SUBMISSIONS FOR PRODUCT CODES OTN AND PAH CAN BE FOUND UNDER MANUFACTURER REPORTS NUMBERS 3005099803-2014-02412 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 OTP. PLEASE SEE ATTACHED SPREADSHEET FOR THE BIMONTHLY SUBMISSION DUE (B)(4) 2014. SUBMISSIONS FOR PRODUCT CODES OTN AND PAH CAN BE FOUND UNDER MANUFACTURER REPORTS NUMBERS 3005099803-2014-02412 AND 3005099803-2014-02415.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374399 PINNACLE PELVIC FLOOR REPAIR KITS MESH, SURGICAL, SYNTHETIC OTP M0068317050

    Patients

    Seq Age Sex Outcome Treatment
    1