BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENTRIX SURGICAL MARIX, THICK 30 UNK

    MDR report key: 7897615 · Received September 20, 2018

    Report

    Report Number
    MW5080030
    Event Type
    Injury
    Date Received
    September 20, 2018
    Date of Event
    September 7, 2018
    Report Date
    September 19, 2018
    Manufacturer
    ACELL, INC.
    Product Code
    FTM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PT UNDERWENT A REDUCTION OF A LARGE VENTRAL HERNIA AND TRANSVERSE ABDOMINAL MUSCLE RELEASE WITH RETRORECTUS PLACEMENT OF BIOLOGICAL MESH (GENTRIX) FOR LARGE VENTRAL HERNIA REPAIR ON (B)(6) 2018. ON (B)(6) 2018, THE PT WAS RETURNED TO SURGERY DUE TO FOUL SMELLING DRAINAGE FROM THE SURGICAL SITE. INTRAOPERATIVELY, SHE WAS FOUND TO HAVE NECROTIZING SOFT TISSUE INFECTION INVOLVING THE POSTERIOR SHEATH AND TRANSVERSE ABDOMINAL MUSCLE, THE PERITONEUM AND THE CONTAMINATED MESH. THE MESH WAS REMOVED. THE PT'S CULTURES GREW ENTEROCOCCUS AVIUM. THE PT REMAINS IN CRITICAL CONDITION REQUIRING REPEAT ABDOMINAL IRRIGATION AND DEBRIDEMENTS AND WOUND VAC IN PLACE. DATES OF USE: (B)(6) 2018 - (B)(6) 2018. DIAGNOSIS OR REASON FOR USE: HERNIA REPAIR. GENTRIX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737508 GENTRIX SURGICAL MARIX, THICK 30 UNK MESH, SURGICAL FTM ACELL, INC. 013345

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| L| S