BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARLEX MESH

    MDR report key: 1118644 · Received August 15, 2008

    Report

    Report Number
    1213643-2008-00401
    Event Type
    Injury
    Date Received
    August 15, 2008
    Report Date
    July 23, 2008
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    PREAMENDME
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFO RECEIVED TO DATE, IT IS UNCLEAR WHICH IMPLANTED MESHES WERE EXPLANTED DURING EITHER THE 2006 OR 2008 PROCEDURES. 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. FOR INFO RELATED TO THE DEVICE IMPLANTED IN 1993; SEE MEDWATCH 1213643-2008-00399. FOR INFO RELATED TO THE DEVICE IMPLANTED IN 1997; SEE MEDWATCH 1213643-2008-00400.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PT THAT HE HAS HAD MULTIPLE MESHES IMPLANTED OVER THE YEARS TO REPAIR APPROX 7 HERNIAS THAT DEVELOPED FOLLOWING SURGERY IN WHICH 85% OF HIS STOMACH WAS REMOVED. BEGINNING AROUND 2004, HE BEGAN DEVELOPING FISSURES (OPENINGS IN HIS ABDOMINAL AREA) THAT FORMED ON THE OUTSIDE OF HIS STOMACH AND HIS BOWELS WERE PROTRUDING. IN 2004, HE HAD SURGERY TO REPAIR ONE FISTULA, IN 2006 TO REPAIR ANOTHER FISTULA, AND IN 2008, THE MOST RECENT FISTULA WAS REPAIRED. SURGEON TOLD HIM THAT ANOTHER FISTULA COULD DEVELOP AT ANYTIME. OPERATIVE REPORTS PROVIDED ADDITIONAL INFO: IN 1993, PT UNDERWENT VENTRAL HERNIA REPAIR WITH MARLEX MESH (STERILE LOT 43IC6139 92-09). IN 1997, PT UNDERWENT RECURRENT INCISIONAL HERNIA REPAIR WITH MARLEX MESH (LOT# 920310). IN 1998, PT UNDERWENT VENTRAL HERNIA REPAIR WITH MARLEX MESH (LOT# 44BIM007). IN 2006, PT UNDERWENT SURGICAL PROCEDURE TO REPAIR FISTULA DURING WHICH MESH WAS EXPLANTED. IN 2008, PT UNDERWENT PROCEDURE TO RESECTION OF SMALL BOWEL FISTULA AND INFECTED MARLEX MESH, LYSIS OF ADHESIONS, ENTERO ENTEROTOMY. POST OPERATIVE DIAGNOSIS: INTRA-ABDOMINAL ABSCESS WITH ENTEROCUTANEOUS FISTULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARLEX MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA 44BIM007

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention