BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T-SLING

    MDR report key: 4203521 · Received October 20, 2014

    Report

    Report Number
    3003990090-2014-00023
    Event Type
    Injury
    Date Received
    October 20, 2014
    Date of Event
    July 11, 2007
    Report Date
    September 23, 2014
    Manufacturer
    HERNIAMESH S.R.L.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    EVENT WAS REPORTED TO CALDERA MEDICAL BY AN ATTORNEY. LEGAL COMPLAINT STATES THAT PT SUFFERED SERIOUS BODILY INJURIES, INCLUDING, BUT NOT LIMITED TO EXTREME PAIN, EROSION OF HER INTERNAL BODILY TISSUE, DYSPAREUNIA, PAINFUL SCARRING, AND OTHER INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666707 T-SLING SURGICAL MESH FTL HERNIAMESH S.R.L. T-SLING 0465

    Patients

    Seq Age Sex Outcome Treatment
    1 Other