BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - DULEX

    MDR report key: 2062414 · Received April 6, 2011

    Report

    Report Number
    1213643-2011-00141
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    May 8, 2005
    Report Date
    November 10, 2010
    Manufacturer
    DAVOL INC
    Product Code
    FTL
    PMA / PMN Number
    K003917
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT'S ATTORNEY INITIALLY REPORTED A COMPOSIX E/X, WHICH WAS FILED WITH THE FDA UNDER MDR 213643-2010-00335 WHEN DAVOL WAS ORIGINALLY MADE AWARE OF THE COMPLAINT. HOWEVER, MEDICAL RECORDS WERE LATER RECEIVED THAT IDENTIFIED AN ADDITIONAL MESH. BASED ON A REVIEW OF THE PT'S MEDICAL RECORDS, PT WAS TREATED FOR A VENTRAL INCISIONAL HERNIA ON (B)(6) 2003 USING A BARD COMPOSIX E/X MESH. ON (B)(6) 2003, PT UNDERWENT AND EXPLORATORY LAPAROTOMY THAT REVEALED A "SINGLE SMALL POCKET OF INFECTION IN THE HERNIA SAC." THE PREVIOUS MESH WAS EXPLANTED. EXPLANTED MESH WAS VERY WELL ATTACHED WITH NO EVIDENCE OF HERNIA RECURRENCE, NO EVIDENCE OF BOWEL DAMAGE OR PROBLEMS WITH BOWEL. ON (B)(6) 2004, PT WAS AGAIN TREATED FOR A VENTRAL HERNIA WITH A BARD DULEX MESH. THAT MESH WAS EXPLANTED ON (B)(6) 2005. THE SURGEON SAID ADHESIONS STUCK TO THE GORE-TEX MESH CAUSED A SMALL BOWEL OBSTRUCTION, WHICH WAS EXCISED. SURGEON NOTED THAT THERE WAS NO MUSCLE UNDER OR ON TOP OF MESH THAT LOOKED AS IF MESH HAD JUST BEEN USED AS A BRIDGE BETWEEN ABDOMINAL WALL MUSCULATURE. ADHESIONS ARE STATED IN THE INSTRUCTIONS FOR USE AS A POSSIBLE ADVERSE REACTION. A PROCEED MESH WAS USED IN THIS REPAIR. THE MEDICAL REPORT STATES THAT THE PT WAS TREATED FOR RECURRENCE, WHICH IS A POSSIBLE ADVERSE REACTION STATED IN THE PRODUCT'S IFU. BASED ON THE INFO AVAILABLE, IT IS UNK WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    BASED ON A REVIEW OF MEDICAL RECORDS PROVIDED BY PT'S ATTORNEY: (B)(6) 2002 - OPEN GASTRIC BYPASS. ON (B)(6) 2003 - REPAIR OF VENTRAL INCISIONAL HERNIA WITH BARD COMPOSIX E/X MESH, LYSIS OF ADHESIONS. ON (B)(6) 2003 - REMOVAL OF VENTRAL HERNIA REPAIR MESH. ON (B)(6) 2004 - LAPAROSCOPIC REPAIR OF VENTRAL INCISIONAL HERNIA WITH BARD DULEX MESH, LYSIS OF ADHESIONS. ON (B)(6) 2005 - EXPLORATORY LAPAROTOMY, LYSIS OF ADHESIONS, RELEASE OF SMALL BOWEL OBSTRUCTION, EXCISION OF OLD MESH, REPAIR OF INCISIONAL HERNIA WITH PROCEED MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH - DULEX FTL DAVOL INC NA 41GNDR16

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention