BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH- COMPOSIX KUGEL

    MDR report key: 2170732 · Received July 12, 2011

    Report

    Report Number
    1213643-2011-00327
    Event Type
    Injury
    Date Received
    July 12, 2011
    Date of Event
    September 22, 2011
    Report Date
    February 13, 2008
    Manufacturer
    DAVOL INC
    Product Code
    FTL
    PMA / PMN Number
    K003323
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    ATTORNEY

    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 ANOTHER EVENT. BASED ON MEDICAL RECORD REVIEW, THE PT UNDERWENT INCARCERATED INCISIONAL HERNIA REPAIR WITH TWO PIECES OF COMPOSIX KUGEL MESH ON (B)(6) 2001. INADVERTENTLY, THE PT SUFFERED AN ENTEROTOMY CAUSED BY THE DISSECTION OF THE HERNIA FROM THE BOWEL. ON (B)(6) 2001, THE PT WAS ADMITTED AFTER IT WAS IDENTIFIED STOOL COULD BE EXPRESSED THROUGH THE MIDLINE. THE MEDICAL RECORDS PROVIDED DO NOT INDICATE A DEVICE RELATED FAILURE AS CAUSING OR CONTRIBUTING TO THE REPORTED EVENT. ADDITIONALLY, ACCORDING TO THE MEDICAL RECORDS THE COMPOSIX KUGEL MESH REMAINS IMPLANTED. SEE MDR 1213643-2007-00989 FOR INFO RELATED TO THE FIRST COMPOSIX KUGEL MESH IMPLANTED ON (B)(6) 2001.

    Description of Event or Problem · 1

    BASED ON MEDICAL RECORDS PROVIDED BY THE PT'S ATTORNEY: ON (B)(6) 2001- PT UNDERWENT INCARCERATED INCISIONAL HERNIA REPAIR WITH TWO PIECES OF COMPOSIX KUGEL MESH. AN INADVERTENT ENTEROTOMY WAS MADE, CAUSED BY THE DISSECTION OF THE HERNIA FROM THE BOWEL. ON (B)(6) 2001- PT WAS ADMITTED, MEDICAL RECORDS NOTE IT WAS IDENTIFIED THAT STOOL COULD BE EXPRESSED FROM THE MIDLINE INCISION. ON (B)(6) 2002- PT UNDERWENT A COLOSTOMY CLOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH- COMPOSIX KUGEL FTL DAVOL INC NA 41GLDP07

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention