BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - VENTRALEX

    MDR report key: 2871980 · Received December 6, 2012

    Report

    Report Number
    1213643-2012-00851
    Event Type
    Injury
    Date Received
    December 6, 2012
    Date of Event
    June 18, 2007
    Report Date
    November 9, 2012
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K021736
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFO PROVIDED, NO DEFINITIVE CONCLUSIONS CAN BE MADE. THE PT HAS MULTIPLE CO-MORBIDITIES INCLUDING SMOKING, MORBID OBESITY, DIABETES AND NUMEROUS OTHER AILMENTS. THERE APPEARS TO BE A PATTERN THAT 2 TO 3 WEEKS POST OP, THE PT CALLS TO REPORT THAT SHE HAS A TRAUMA, SUCH AS A FALL, COMPLAINS OF PAIN AND REQUESTS ADD'L PAIN MANAGEMENT. THE PT HAD A DIFFICULT SURGICAL RECOVERY WITH POST-OP RESPIRATORY FAILURE WITH FLUID OVERLOAD, AND WAS READMITTED WITH A POST-OP INFECTION, INCISIONAL CELLULITIS AND FISTULA. THERE ARE NO RECORDS PROVIDED AFTER 2007. THE INFO PROVIDED INDICATES THAT THE PT DEVELOPED AND WAS TREATED FOR FISTULA AND INFECTION, WHICH ARE KNOWN ADVERSE EVENTS LISTED IN THE IFU. THERE IS NO INDICATION OF DEFECTIVE MESH. ADDITIONALLY, NO PRODUCT HAS BEEN RETURNED FOR EVAL. IF ANY ADD'L INFO IS OBTAINED, A F/U MDR WILL BE SUBMITTED. SEE MDR 1213643-2009-00354 FOR INFO RELATED TO THE COMPOSIX MESH (#1) IMPLANTED ON (B)(6) 1998. SEE MDR 1213643-2009-00355 FOR INFO RELATED TO THE COMPOSIX MESH (#2) IMPLANTED ON (B)(6) 1999. SEE MDR 1213643-2009-00356 FOR INFO RELATED TO THE COMPOSIX KUGEL MESH (#3) IMPLANTED ON (B)(6) 2000.

    Description of Event or Problem · 1

    FOLLOWING IS BASED ON MEDICAL RECORDS PROVIDED BY THE PT'S ATTORNEY: ON (B)(6) 1998, REPAIR OF INCARCERATED VENTRAL INCISIONAL HERNIA WITH IMPLANT OF COMPOSIX MESH #1. ON (B)(6) 1999, REPAIR OF NEW INCARCERATED VENTRAL INCISIONAL HERNIA, INFERIOR TO MESH #1, WITH IMPLANT OF COMPOSIX MESH #2. ON (B)(6) 2000, REPAIR OF RECURRENT VENTRAL INCISIONAL HERNIA WITH IMPLANT OF A 'TRIMMED' COMPOSIX KUGEL MESH #3, SUTURED TO MESH #2. ON (B)(6) 2001 AND (B)(6) 2002, PT COMPLAINED OF PAIN. INCISION HEALED, NO HERNIA. FATTY TISSUE PULLING ON FASCIA AND POSSIBLE ADHESIONS. ADVISED TO LOSE WEIGHT. ON (B)(6) 2004, REPAIR OF NEW VENTRAL INCISIONAL HERNIA, SUPERIOR TO UMBILICUS, WITH IMPLANT OF VENTRALEX MESH #4. ON (B)(6) 2004, WOUND WITH SKIN SEPARATION HAD SEROSANGUINEOUS DRAINAGE, NO INFECTION. ON (B)(6) 2007, MESH #1, #2, AND #3 EXPLANTED. MULTIPLE LOOPS OF SMALL BOWEL ADHERENT TO MESH. SMALL BOWEL WAS RESECTED X2. ON (B)(6) 2007, ER: WOUND INTACT, NO DISCHARGE. AFTER LAST SURGERY, PT SIGNED OUT AMA AND HAD NOT HAD A WOUND DRESSING CHANGE SINCE. ON (B)(6) 2007, ADMITTED WITH POST-OP INFECTION, CELLULITIS, FISTULA AND NUMEROUS OTHER COMPLICATIONS. PT TRANSFERRED TO TERTIARY CARE CENTER WITH FISTULA. ON (B)(6) 2007, EXCISION OF NECROTIC TISSUE, AND UNDERLYING BOWEL OF FISTULA SITE WAS SEEN. THE SEROSA OF THE ANTERIOR PORTION OF THE EXPOSED BOWEL APPEARED TO BE INTACT IN THE AREA OF THE FISTULA. IT APPEARS VENTRALEX MESH #4 WAS EXPLANTED, AND WOUND DEBRIDED. ON (B)(6) 2007, DEBRIDEMENT FOR A NONHEALING ABDOMINAL WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH - VENTRALEX FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43IOD400

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention