BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MESH-COMPOSIX KUGEL

    MDR report key: 655385 · Received December 13, 2005

    Report

    Report Number
    1213643-2005-00212
    Event Type
    Malfunction
    Date Received
    December 13, 2005
    Date of Event
    November 28, 2005
    Report Date
    November 28, 2005
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    MEMORY RING EXPOSED PRIOR TO PLACEMENT. DETERMINED TO BE A BROKEN RECOIL RING UPON RECEIPT OF PRODUCT. 12/2005.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH-COMPOSIX KUGEL SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. * 43FPD350

    Patients

    Seq Age Sex Outcome Treatment
    1 *