BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD FLAT MESH

    MDR report key: 2150606 · Received June 23, 2011

    Report

    Report Number
    1213643-2011-00303
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    July 1, 2005
    Report Date
    June 17, 2010
    Manufacturer
    DAVOL INC.
    Product Code
    FTL
    PMA / PMN Number
    PREAMENDMEN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    INITIALLY, THE ATTORNEY REPORTED THAT A SINGLE EVENT OF THE IMPLANT OF A COMPOSIX E/X MESH OCCURRED; HOWEVER, MEDICAL RECORDS WERE RECEIVED AND A REVIEW OF THESE RECORDS IDENTIFIED ANOTHER EVENT. BASED ON THE MEDICAL RECORD REVIEW, THE PT UNDERWENT RECURRENT INCISIONAL HERNIA REPAIR WITH BARD MESH ON (B)(6) 2000. APPROX TWO WEEKS POST IMPLANT, THE PT WAS ADMITTED FOR CELLULITIS ON THE LOWER ABDOMINAL WALL. THE MEDICAL RECORDS NOTE IT WAS NOT INVOLVING THE UPPER MIDLINE INCISION. SUBSEQUENTLY, THE PT UNDERWENT INCISION AND DRAINAGE OF AN ABDOMINAL WALL ABSCESS. BASED ON THE INFO PROVIDED, IT IS UNK WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE PT IS MORBIDLY OBESE AND WAS TREATED FOR A RECURRENCE PRIOR TO IMPLANT OF BARD MESH. THE MEDICAL RECORDS NOTE THAT THE PT USED A VARIETY OF TREATMENTS ON HER ABDOMEN INCLUDING HYDROGEN PEROXIDE, ALCOHOL, BLEACH, LAUNDRY DETERGENT AND SOAP. THE INFO PROVIDED INDICATES THAT THE PT DEVELOPED AND WAS TREATED FOR AN INFECTION. THE WARNING SECTION OF THE IFU STATES "IF AN INFECTION DEVELOPES TREATS THE INFECTION AGGRESSIVELY. AN UNRESOLVED INFECTION, HOWEVER, MAY REQUIRE REMOVAL OF THE PROSTHESIS." ADDITIONALLY, NO SAMPLE WAS RETURNED FOR EVALUATION. WHILE RECURRENCE AND INFECTION ARE KNOWN ADVERSE EVENTS LISTED IN THE IFU, NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. REFER TO 1213643-2010-00055 FOR INFO RELATED TO THE COMPOSIX E/X MESH IMPLANTED ON (B)(6) 2005.

    Description of Event or Problem · 1

    BASED ON THE MEDICAL RECORDS PROVIDED BY THE PT'S ATTORNEY: (B)(6) 2000 - PT UNDERWENT EXPLORATORY LAPAROTOMY AND REPAIR OF RECURRENT INCISIONAL HERNIA WITH BARD MESH. A FLUID COLLECTION WAS ENCOUNTERED AND DRAINED. LYSIS OF ADHESIONS WAS PERFORMED. ON (B)(6) 2000 - PT ADMITTED FOR CELLULITIS LOWER ABDOMINAL WALL. PT UNDERWENT 6 INCISION AND DRAINAGE OF ABDOMINAL WALL ABSCESS. SEROSANGUINOUS FLUID WAS OBTAINED, A DRAIN WAS PLACED. PT DISCHARGED ON (B)(6) 2000. ON (B)(6) 2005 - PT UNDERWENT HERNIA REPAIR WITH COMPOSIX E/X. EXTENSIVE ADHESIOLYSIS WAS PERFORMED. BARD MESH WAS IDENTIFIED, A PARTIAL EXPLANT PERFORMED. ON (B)(6) 2005 - PT ADMITTED FOR FEVER, PAIN, WOUND BREAKDOWN. ON (B)(6) 2005 - PT UNDERWENT EXCISION OF COMPOSIX E/X MESH AND IMPLANT OF NON-BARD GRAFT. ON (B)(6) 2005 - WOUND VAC PLACED AND PT DISCHARGED. ON (B)(6) 2009 - PT ADMITTED WITH SEVERE ABDOMINAL PAIN; DISCHARGED ON (B)(6) 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD FLAT MESH FTL DAVOL INC. NA 44EIM382

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| R