BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T-SLING

    MDR report key: 2442375 · Received January 26, 2012

    Report

    Report Number
    3003990090-2012-00008
    Event Type
    Injury
    Date Received
    January 26, 2012
    Report Date
    January 24, 2012
    Manufacturer
    HERNIAMESH SR1
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTED BY AN ATTORNEY. PT CLAIMS TO HAVE SUFFERED SERIOUS BODILY INJURY, INCLUDING EXTREME PAIN, EROSION OF HER INTERNAL BODILY TISSUES AND OTHER INJURIES SIMILAR TO THE ONES DESCRIBED IN THE FDA'S PUBLIC HEALTH ADVISORY OF 10/21/2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 T-SLING SURGICAL MESH FTL HERNIAMESH SR1 CAL-TS10 0189

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other