BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRAFT MESH VENTRIO ST.

    MDR report key: 5045367 · Received August 27, 2015

    Report

    Report Number
    MW5055844
    Event Type
    Injury
    Date Received
    August 27, 2015
    Date of Event
    May 13, 2015
    Report Date
    August 13, 2015
    Manufacturer
    DAVOL A BARD CO.
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PER OP REPORT: THE EDGES OF THE MESH WERE IDENTIFIED AND THE SOFT TISSUE AND OMENTUM ADHERENT TO THE UNDERSURFACE OF THE MESH WERE TAKEN AWAY FROM THE UNDERSURFACE OF THE MESH USING BLUNT DISSECTION AND THERE WAS NOTED TO BE A WHITISH PUS MATERIAL ON THE SURFACE OF THE MESH. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569565 GRAFT MESH VENTRIO ST. MESH FTL DAVOL A BARD CO. 11UZB0230

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization