BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAPRO ABDOMINAL WALL MESH

    MDR report key: 5221744 · Received November 13, 2015

    Report

    Report Number
    5221744
    Event Type
    Malfunction
    Date Received
    November 13, 2015
    Date of Event
    August 6, 2014
    Report Date
    November 6, 2015
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PRE-OP DIAGNOSIS: RECURRENT VENTRAL INCISIONAL HERNIA. POST-OP DIAGNOSIS: SAME. PROCEDURE(S): VENTRAL HERNIA REPAIR WITH BILATERAL COMPONENT SEPARATION AND STRATTICE MESH UNDERLAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751878 ULTRAPRO ABDOMINAL WALL MESH MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR