BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLAMEND

    MDR report key: 2120298 · Received June 1, 2011

    Report

    Report Number
    1213643-2011-00243
    Event Type
    Injury
    Date Received
    June 1, 2011
    Date of Event
    September 2, 2008
    Report Date
    July 1, 2010
    Manufacturer
    DAVOL INC.
    Product Code
    FTM
    PMA / PMN Number
    K052322
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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 REVIEW OF MEDICAL RECORDS, ON (B)(6) 2008 THE PATIENT UNDERWENT EXPLORATORY LAPAROTOMY WITH MESH RESECTION. A SMALL ENTEROTOMY WAS IDENTIFIED AND REPAIRED, A SMALL BOWEL RESECTION WAS PERFORMED. THE ABDOMEN WAS IRRIGATED WITH SALINE AND THE FASCIA WAS CLOSED WITH A COLLAMEND MESH IMPLANT. THE PATIENT WAS DISCHARGED ON (B)(6) 2008. APPROXIMATELY SIX MONTHS LATER THE PATIENT WAS ADMITTED FOR VOMITING, DIARRHEA AND DEHYDRATION AND SUBSEQUENTLY UNDERWENT INCISION AND DRAINAGE OF ABDOMINAL WALL ABSCESS. THE MEDICAL RECORDS PROVIDED DO NOT INDICATE A DEVICE RELATED FAILURE AS CAUSING OR CONTRIBUTING TO THE REPORTED EVENT. THE PATIENT HAS MULTIPLE MEDICAL ISSUES INCLUDING CHRONIC DEPENDABILITY ON HOSPICE CARE, HERNIA RECURRENCE AND ABSCESS DRAINAGE PRIOR TO COLLAMEND IMPLANT. ADDITIONALLY, COLLAMEND REMAINS IMPLANTED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. SEE MDR 1213643-2010-00117 FOR INFORMATION RELATED TO THE COMPOSIX E/X MESH IMPLANTED ON (B)(6) 2004.

    Description of Event or Problem · 1

    BASED ON MEDICAL RECORDS PROVIDED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2004 - PATIENT UNDERWENT REPAIR OF INCARCERATED INCISIONAL VENTRAL HERNIAL WITH COMPOSIX E/X. ON (B)(6) 2007 - PATIENT UNDERWENT INCISION AND DRAINAGE OF ABSCESS WITH AEROBIC CULTURES. THE MEDICAL RECORDS NOTE A POSSIBLE INFECTED MESH IS PRESENT. ON (B)(6) 2008 - PATIENT ADMITTED FOR ABDOMINAL WALL INFECTION AND ENTEROCUTANEOUS FISTULA. PATIENT UNDERWENT EXPLORATORY LAPAROTOMY WITH MESH RESECTION. A SMALL ENTERTOMY WAS IDENTIFIED AND REPAIRED, A SMALL BOWEL RESECTION WAS PERFORMED. THE ABDOMEN WAS IRRIGATED WITH SALINE AND THE FASCIA WAS CLOSED WITH A COLLAMEND MESH IMPLANT. PATIENT DISCHARGED ON (B)(6) 2008. ON (B)(6) 2008 - PATIENT ADMITTED FOR VOMITING AND DIARRHEA. ON (B)(6) 2008 - PATIENT UNDERWENT INCISION AND DRAINAGE OF ABDOMINAL WALL ABSCESS. THE SUBFASCIAL ABDOMINAL WALL ABSCESS CAVITY LEAKED A PUS FLUID AND WAS SUCTIONED DRY AND PACKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLAMEND FTM DAVOL INC. NA DARF0400

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention