BEUDAMED
    FDA Adverse Event Injury Summary report: N

    0113680-COMPOSIX MESH 6 X 8

    MDR report key: 346273 · Received August 7, 2001

    Report

    Report Number
    1213643-2001-00038
    Event Type
    Injury
    Date Received
    August 7, 2001
    Date of Event
    June 15, 2001
    Report Date
    August 7, 2001
    Manufacturer
    C.R. BARD, INC. (PUERTO RICO)
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT INFECTION. IMPLANTED IN 2001. TO ER 10 DAYS LATER WITH ABDOMINAL PAIN AND FEVER. MESH EXPLANTED 4 DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35566 0113680-COMPOSIX MESH 6 X 8 350101104-MESH COMPOSIX FTL C.R. BARD, INC. (PUERTO RICO) * 43JKD161

    Patients

    Seq Age Sex Outcome Treatment
    1 * Life Threatening