BEUDAMED
    FDA Adverse Event Injury Summary report: N

    0113480-COMPOSIX MESH 4 X 8

    MDR report key: 368817 · Received December 28, 2001

    Report

    Report Number
    1213643-2001-00060
    Event Type
    Injury
    Date Received
    December 28, 2001
    Date of Event
    November 28, 2001
    Report Date
    December 28, 2001
    Manufacturer
    C.R. BARD, INC. (PUERTO RICO)
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT INFECTION. VENTRAL HERNIA. MESH PLACED 2001. NON-HEALING SINUS TRACT. MESH REMOVED ALMOST SIX MONTHS LATER. SEROMA HAD FORMED BETWEEN MESH AND EXPANDED POLY-TETRA-FLUORO-ETHYLENE LAYERS AND BECOME INFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58717 0113480-COMPOSIX MESH 4 X 8 350101104-MESH COMPOSIX FTL C.R. BARD, INC. (PUERTO RICO) * 43CLD175

    Patients

    Seq Age Sex Outcome Treatment
    1 * Life Threatening