BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XENMATRIX SURGICAL GRAFT

    MDR report key: 2213487 · Received August 8, 2011

    Report

    Report Number
    2213487
    Event Type
    Malfunction
    Date Received
    August 8, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 8, 2011
    Manufacturer
    BARD
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD A PARASTOMAL HERNIA REPAIR WITH MESH INSERTION. PATIENT RETURNED TO SURGERY 6 DAYS LATER DUE TO THE DISINTEGRATION OF THE MESH WITH FAILURE.====================== MANUFACTURER RESPONSE FOR BARD XENMATRIX SURGICAL GRAFT, BARD (PER SITE REPORTER)======================WANTED RETURN OF DEFECTIVE MESH SENT BACK TO THEM ONCE AUTHORIZATION WAS GIVEN BY PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XENMATRIX SURGICAL GRAFT MESH, SURGICAL GRAFT FTL BARD 1161928 HUVBBL13

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR NO OTHER THERAPIES