BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 709428 · Received May 5, 2006

    Report

    Report Number
    2210968-2006-00348
    Event Type
    Injury
    Date Received
    May 5, 2006
    Report Date
    April 6, 2006
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SLING PROCEDURE IN 2005. THERE WERE NO INTRAOPERATIVE OR IMMEDIATE POSTOPERATIVE COMPLICATIONS, AND THE PATIENT HAD A NORMAL VOIDING PATTERN. THE PATIENT WAS DISCHARGED ONE DAY LATER AND THERE WERE NO COMPLAINTS OR UNDUE EVENTS AT THE 8-WEEK FOLLOW UP VISIT. AT THE 6-MONTH REVIEW, THE PATIENT COMPLAINED OF DE-NOVO URGENCY OF MILD SEVERITY WITH AN ONSET OF 12/2005. THE PATIENT WAS TREATED WITH DITROPAN FROM 12/2005 TO 03/2006 AND WITH CERIS FROM 03/2006 TO PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 1290519

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention