BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVICOL 2CM X 7CM 1.0MM

    MDR report key: 3152249 · Received March 6, 2013

    Report

    Report Number
    9617613-2013-00078
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    October 24, 2007
    Report Date
    February 8, 2013
    Manufacturer
    COVIDIEN, FORMERLY TISSUE
    Product Code
    FTL
    PMA / PMN Number
    K992556
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IMP REF # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96590 PELVICOL 2CM X 7CM 1.0MM PELVICOL MESH FTL COVIDIEN, FORMERLY TISSUE

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other