BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - VENTRALEX

    MDR report key: 786207 · Received November 16, 2006

    Report

    Report Number
    1213643-2006-00345
    Event Type
    Injury
    Date Received
    November 16, 2006
    Date of Event
    September 20, 2006
    Report Date
    November 16, 2006
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    TWO PATIENTS WITH UMBILICAL HERNIAS, BOTH IMPLANTED WITH SMALL VENTRALEX (0010301, LOT #41IPD365); ONE TWO MOS LATER, BY THE SAME SURGEON. BOTH PRESENTED WITH A SIMILAR REACTION--GRANULATED TISSUE AROUND THE EDGE OF THE MESH, TISSUE WAS RED AND HARD, REACTIVE TISSUE--NOT AN INFECTION. BOTH HAD THE MESH EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH - VENTRALEX SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. * 43IPD365

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention