BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH

    MDR report key: 1063370 · Received June 19, 2008

    Report

    Report Number
    1213643-2008-00342
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    May 18, 2007
    Report Date
    May 20, 2008
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K971745
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PROD HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE WILL SUBMIT A F/U REPORT WHEN/IF PROD IS RETURNED FOR EVAL OR ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ATTY REPORTED: IN 2002, PT UNDERWENT REPAIR OF A RECURRENT VENTRAL ABDOMINAL WALL INCARCERATED HERNIA WITH A BARD COMPOSIX MESH. THE MESH WAS PLACED UNDERNEATH OF FASCIA AND SUTURED. IN 2007, PT SOUGHT MEDICAL TREATMENT DUE TO SEVERE ABDOMINAL. PT'S CONDITION WORSENED PROGRESSIVELY. A CT SCAN OF THE PT'S ABDOMEN REVEALED A SMALL BOWEL OBSTRUCTION. HOSPITALIZATION AND SURGERY WERE IMMEDIATELY NECESSARY. ON THE SAME DAY, PT WAS ADMITTED AND UNDERWENT AN EMERGENCY EXPLORATORY LAPAROTOMY WITH EXTENSIVE LYSIS OF ADHESIONS WITH SMALL BOWEL ANASTOMOSIS. PT WAS REQUIRED TO REMAIN IN THE HOSP FOR 5 DAYS FOLLOWING THE SURGERY. ON OR ABOUT NINE DAYS LATER, PT PRESENTED TO THE ER WITH COMPLAINTS OF ABDOMINAL PAIN. A PHYSICAL EXAM REVEALED REDNESS AT THE BOTTOM OF THE WOUND AND FEVER OF 102 DEGREES. PT WAS ADMITTED. HISTORY AND PHYSICAL REVEALED PT UNDERWENT AN EXPLORATORY LAPAROTOMY WITH BOWEL RESECTION APPROX 10 DAYS PRIOR. A CT SCAN OF PT'S ABDOMEN REVEALED A 7 INCH X 7 INCH ABSCESS IN THE LOWER PORTION OF THE ABDOMINAL CAVITY. AN 8 INCH FRENCH DRAIN WAS PLACED AND APPROX 60 CC OF FLUID WAS ASPIRATED. PT WAS REQUIRED TO REMAIN IN THE HOSP FOR 3 DAYS TO BE TREATED WITH ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R