BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD FLAT MESH

    MDR report key: 1289066 · Received January 13, 2009

    Report

    Report Number
    1213643-2009-00030
    Event Type
    Injury
    Date Received
    January 13, 2009
    Date of Event
    January 23, 2007
    Report Date
    December 15, 2008
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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 EVALUATION OR ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ATTORNEY REPORTED: N 1985--THE PT UNDERWENT A HERNIA REPAIR PROCEDURE WITH PLACEMENT OF A BARD MESH PATCH. IN 2005-- THE PT PRESENTED TO THE HOSPITAL WITH COMPLAINTS OF SEVERE PAIN AND SWELLING OF THE ABDOMINAL WALL. A CT SCAN WAS PERFORMED WITH NOTED PRESENCE OF AN INTRAABDOMINAL ABSCESS. THE PT WAS HOSPITALIZED FOR THREE DAYS AND UNDERWENT DRAINAGE OF THE ABDOMINAL ABSCESS. APPROX THREE MONTHS LATER-- THE PT PRESENTED TO THE HOSPITAL WITH COMPLAINTS OF SEVERE PAIN AND SWELLING OF THE ABDOMINAL WALL. A CT SCAN WAS PERFORMED WITH NOTED PRESENCE OF AN INTRAABDOMINAL ABSCESS. THE PT WAS HOSPITALIZED FOR TWO DAYS AND UNDERWENT DRAINAGE OF THE ABDOMINAL ABSCESS. IN EARLY 2007- THE PT UNDERWENT SURGERY TO HAVE THE MESH PATCH EXPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R