BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGIPRO 6 X 6 MONOFILAMENT MESH

    MDR report key: 3964867 · Received July 17, 2014

    Report

    Report Number
    1219930-2014-00545
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    October 11, 2012
    Report Date
    July 7, 2014
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    FTL
    PMA / PMN Number
    K982575
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE PATIENT ALLEGED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420454 SURGIPRO 6 X 6 MONOFILAMENT MESH NONE FTL COVIDIEN, FORMERLY US SURGICAL SPMM66 A2G0367X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other