BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH

    MDR report key: 1081582 · Received July 24, 2008

    Report

    Report Number
    1213643-2008-00382
    Event Type
    Injury
    Date Received
    July 24, 2008
    Date of Event
    March 12, 2007
    Report Date
    July 7, 2008
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K971745
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE WILL SUBMIT A FOLLOW UP REPORT WHEN/IF PRODUCT IS RETURNED FOR EVAL OR ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ATTORNEY REPORTED: IN EARLY 2006 - THE PT UNDERWENT AN INCISIONAL HERNIA REPAIR PROCEDURE WITH IMPLANT OF A COMPOSIX MESH PATCH. IN 2007 - THE PT UNDERWENT AN EXPLORATORY LAPAROTOMY WITH REMOVAL OF THE COMPOSIX MESH PATCH. PT SUFFERED AN ABDOMINAL INFECTION, EXPOSURE OF THE MESH, ADHESIONS, AND FUSION OF SEVERAL LOOPS OF THE BOWEL TO THE MESH AS A RESULT OF THE FAILED MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43BPD225

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention