BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TVT-S

    MDR report key: 1234515 · Received November 15, 2008

    Report

    Report Number
    MW5009007
    Event Type
    Injury
    Date Received
    November 15, 2008
    Date of Event
    November 14, 2008
    Report Date
    November 15, 2008
    Manufacturer
    JNJ
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    H/O OF TVT-S 2007 -AT OUTSIDE INSTITUTION AND WITH A DIFFERENT PROVIDER- PRESENTED 2008, C/O DYSPAREUNIA SINCE THE PROCEDURE. EXAM WAS NOTABLE FOR WHAT APPEARED TO BE THE SLING BEING READILY PALPABLE BENEATH THE MID-URETHRA. AT TIME OF SURGERY, PATIENT WAS FOUND TO HAVE: RETAINED FOREIGN BODY ASSOCIATED WITH THE SLING - NAMELY THE FINGER PAD FROM THE INTRODUCER. THE SLING ITSELF WAS FOLDED OVER ON ITSELF AND THE FOLDED EDGE WAS LYING AGAINST THE URETHRA. THE CONCERNING EVENT IS NOT SO MUCH THE MAL-PLACEMENT OF THE SLING, BUT THE RETAINED FOREIGN BODY -PART OF THE INTRODUCER MECHANISM-

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TVT-S MID-URETHRAL SLING FTL JNJ

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization