BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - VENTRALEX

    MDR report key: 2170036 · Received July 12, 2011

    Report

    Report Number
    1213643-2011-00332
    Event Type
    Injury
    Date Received
    July 12, 2011
    Date of Event
    October 13, 2003
    Report Date
    March 26, 2008
    Manufacturer
    DAVOL INC
    Product Code
    FTL
    PMA / PMN Number
    K021736
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIALLY THE ATTORNEY REPORTED THAT A SINGLE EVENT OF THE IMPLANT OF A COMPOSIX KUGEL MESH OCCURRED, HOWEVER, MEDICAL RECORDS WERE RECEIVED AND A REVIEW OF THESE RECORDS IDENTIFIED TWO ADD'L EVENTS. BASED ON THE MEDICAL RECORD REVIEW THE PT UNDERWENT INCISIONAL HERNIA REPAIR WITH COMPOSIX E/X ON (B)(6) 2003. APPROX 3 MONTHS POST IMPLANT THE PT UNDERWENT REPAIR OF A RECURRENT VENTRAL HERNIA WITH VENTRALEX MESH. ON (B)(6) 2003 THE PT UNDERWENT REPAIR OF A RECURRENT VENTRAL HERNIA WITH COMPOSIX KUGEL. EXTENSIVE ADHESIOLYSIS WERE PERFORMED. ON (B)(6) 2005, THE PT UNDERWENT EXPLORATORY LAPAROTOMY. THE COMPOSIX KUGEL MESH APPEARED TO BE INFECTED, AND WAS THEREFORE EXCISED. BASED ON THE INFO PROVIDED IT IS UNK WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE PT HAD A SIGNIFICANT HISTORY OF ABDOMINAL REPAIRS INCLUDING A RUPTURED COLON SECONDARY TO DIVERTICULAR DISEASE IN 2001. THE INFO PROVIDED INDICATES THE PT DEVELOPED, AND WAS TREATED FOR A RECURRENCE. THE PRODUCT IFU LISTS RECURRENCE AS A KNOWN ADVERSE REACTION. ADDITIONALLY, ACCORDING TO THE MEDICAL RECORDS THE MESH REMAINS IMPLANTED. SEE MDR 1213643-2007-00841 FOR INFO RELATED TO THE COMPOSIX KUGEL MESH IMPLANTED ON (B)(6) 2003. SEE MDR 1213643-2011-00331 FOR INFO RELATED TO THE COMPOSIX E/X MESH ON (B)(6) 2003.

    Description of Event or Problem · 1

    BASED ON THE MEDICAL RECORDS PROVIDED BY THE PT'S ATTORNEY: ON (B)(6) 2001 - PT UNDERWENT REPAIR OF RUPTURED COLON AND COLOSTOMY FOR DIVERTICULAR DISEASE. ON (B)(6) 2002 - PT UNDERWENT TAKEDOWN PROCEDURE AND CLOSURE OF COLOSTOMY. ON (B)(6) 2003 - PT UNDERWENT REPAIR OF VENTRAL INCISIONAL HERNIA WITH COMPOSIX E/X. ON (B)(6) 2003 - PT UNDERWENT REPAIR OF RECURRENT VENTRAL HERNIA WITH VENTRALEX MESH. ON (B)(6) 2003 - PT UNDERWENT REPAIR OF RECURRENT VENTRAL HERNIA WITH COMPOSIX KUGEL. LYSIS OF ADHESIONS WERE PERFORMED. ON (B)(6) 2005 - PT UNDERWENT EXCISION OF COMPOSIX KUGEL. MEDICAL RECORDS NOTE THAT A PORTION OF THE MESH APPEARED TO BE ATTACHED TO THE SMALL BOWEL AND DURING DISSECTION A SMALL PERFORATION WAS MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH - VENTRALEX FTL DAVOL INC NA 41ANDD13

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention