BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGIPRO 6X6 MONOFILAMENT MESH

    MDR report key: 3902253 · Received June 25, 2014

    Report

    Report Number
    1219930-2014-00473
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    February 20, 2013
    Report Date
    June 9, 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
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: HERNIA. ACCORDING TO THE REPORTER: THE PT ALLEGED INJURY. PT CONTINUES TO SUFFER FROM UNBEARABLE PAIN AND ALLEGES THAT THE MESH HAS BECOME INFECTED, DISLODGED, DISINTEGRATING, AND ERODING INTO (B)(6) BODY IN GENERAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370313 SURGIPRO 6X6 MONOFILAMENT MESH SURGIPRO MESH FTL COVIDIEN, FORMERLY US SURGICAL A2G0594X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other