BEUDAMED
    FDA Adverse Event Other Summary report: N

    T-SLING

    MDR report key: 2171881 · Received May 29, 2007

    Report

    Report Number
    3003990090-2007-00003
    Event Type
    Other
    Date Received
    May 29, 2007
    Date of Event
    November 28, 2006
    Report Date
    May 22, 2007
    Manufacturer
    HERNIAMESH, S.R.L.
    Product Code
    FTL
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SURGEON TRIED TRANSVAGINAL APPROACH WITH SLING. SURGEON CYSTOID PATIENT BEFORE PULLING MESH. AFTER COMPLETING PROCEDURE, SURGEON CYSTOID AGAIN BECAUSE THERE WAS AN UNUSUAL AMOUNT OF BLEEDING. MESH WAS IN BLADDER. SURGEON EXPLANTED MESH, THEN USED TRANSOBTURATOR APPROACH FOR SECOND MESH PLACEMENT. SURGEON REPORTED THIS SECOND PLACEMENT A SUCCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 T-SLING POLYPROPYLENE SURGICAL MESH - FTL FTL HERNIAMESH, S.R.L. CAL-TSIO 0378

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other