BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON ENDO-SURGERY, INC

    MDR report key: 2061784 · Received April 13, 2011

    Report

    Report Number
    MW5020286
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    February 21, 2011
    Report Date
    April 13, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, INC
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE OPERATIVE REPORT, "THE MESH, WHICH HAD BEEN PREVIOUSLY PLACED, WAS SEEN TO HAVE PULLED AWAY FROM THE ATTACHMENTS IN THE LEFT LATERAL SUPERIOR AND INFERIOR AREAS AND A PORTION OF THE FASCIAL FIXATION HAD TORN THROUGH THE MESH." NO ADVERSE EFFECT ON THE PT. SURGEON: DR. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ENDO-SURGERY, INC PHYSIOMESH FTL ETHICON ENDO-SURGERY, INC CJ9CWDZO

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR