BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIODESIGN SURGISIS

    MDR report key: 2083032 · Received May 4, 2011

    Report

    Report Number
    MW5020527
    Event Type
    Injury
    Date Received
    May 4, 2011
    Date of Event
    November 30, 2010
    Report Date
    May 4, 2011
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PRE-OP DIAGNOSIS: ABDOMINAL PAIN/ ABNORMAL CT SCAN WITH INFECTED MESH HEMATOMA AND POSSIBLE BOWEL FISTULIZATION. POSTOPERATIVE DIAGNOSIS: MESH INFECTION WITH SUPRA- AND INFRA-FASCIAL COLLECTIONS OF PUS, ABSCESS, INFECTED MESH, FISTULIZED OR SEVERELY ADHERENT SMALL BOWEL TO THE MESH AND THE ABSCESS. OPERATIVE PROCEDURE: LAPAROSCOPY, COVERED TO LAPAROTOMY, LAPAROSCOPIC PLACEMENT OF GASTRIC TUBE IN THE REMNANT USING A 20-FRENCH FOLEY, OPEN SMALL BOWEL RESECTION, REMOVAL OF MESH, PARTIAL OMENTECTOMY, WOUND PACKING AND DRAINAGE OF INTRA-ABDOMINAL ABSCESS AS WELL AS SUBCUTANEOUS ABSCESS. POST-OP DX: SMALL BOWEL OBSTRUCTION AND ABDOMINAL WALL INFECTION MESH INFECTION. PROCEDURE: LAPAROSCOPY, EXCISION OF MESH, DRAINAGE OF INTRAABDOMINAL ABSCESS, BOWEL RESECTION X 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIODESIGN SURGISIS HERNIA GRAFT FTL LB466152

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| L| S