BEUDAMED
    FDA Adverse Event Injury Summary report: N

    0010207 COMPOSIX KUGEL OVAL 10 X 13

    MDR report key: 434613 · Received December 20, 2002

    Report

    Report Number
    1213643-2002-00060
    Event Type
    Injury
    Date Received
    December 20, 2002
    Date of Event
    October 6, 2002
    Report Date
    November 25, 2002
    Manufacturer
    DAVOL, INC. (RI)
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BOWEL FISTULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 0010207 COMPOSIX KUGEL OVAL 10 X 13 35010106 KUGEL PATCH FTL DAVOL, INC. (RI) * 41AMDD10

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention