BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLYX SIS SYSTEM

    MDR report key: 3897133 · Received June 26, 2014

    Report

    Report Number
    3005099803-2014-02415
    Event Type
    Injury
    Date Received
    June 26, 2014
    Report Date
    May 1, 2014
    Product Code
    PAH
    PMA / PMN Number
    K081275
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    THIS MANUFACTURER REPORT IS BEING SENT AS A REQUIREMENT UNDER SUMMARY REPORTING EXEMPTION APPROVAL NUMBER ¿ (B)(4) FOR PRODUCT CODE PAH. PLEASE SEE ATTACHED FOR CORRECTION SUBMISSION DUE AUGUST 31, 2014. (B)(4).

    Description of Event or Problem · 1

    (B)(4). SUBMISSIONS FOR PRODUCT CODES OTN AND OTP CAN BE FOUND UNDER MANUFACTURER REPORTS NUMBERS 3005099803-2014-02412 AND 3005099803-2014-02411.

    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 PAH. PLEASE SEE ATTACHED SPREADSHEET FOR THE BIMONTHLY SUBMISSION DUE JUNE 30, 2014. SUBMISSIONS FOR PRODUCT CODES OTN AND OTP CAN BE FOUND UNDER MANUFACTURER REPORTS NUMBERS 3005099803-2014-02412 AND 3005099803-2014-02411.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376101 SOLYX SIS SYSTEM MESH, SURGICAL, POLYMERIC PAH UNK660

    Patients

    Seq Age Sex Outcome Treatment
    1