BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3082285 · Received April 29, 2013

    Report

    Report Number
    2210968-2013-04614
    Event Type
    Injury
    Date Received
    April 29, 2013
    Report Date
    April 1, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SLING PROCEDURE IN (B)(6) 2011. CONCOMITANTLY, THE PATIENT UNDERWENT A VAGINAL HYSTERECTOMY AND ROBOTIC SACROCOLPOPEXY. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED PERSISTENT VAGINAL PAIN AND MESH EROSION. THE PATIENT HAD BEEN TAKEN TO THE OPERATING ROOM ON TWO OCCASIONS AS WELL AS TRIMMING IN THE OFFICE, BUT CONTINUED TO HAVE VAGINAL SPOTTING, PAIN, AND WAS UNABLE TO HAVE COITAL ACTIVITY BECAUSE OF THE PAIN FOR HER PARTNER. SHE WAS FOUND TO HAVE A SIX CENTIMETER LINE DOWN THE ANTERIOR VAGINAL WALL THAT WAS OVER ON HER RIGHT SIDE WITH A RIDGE AND FIBERS OF THE MESH THAT WERE EXPOSED. AT THE APEX, THERE WAS A LARGER PIECE ABOUT ONE CENTIMETER EXPOSED MESH. THE PATIENT UNDERWENT AN EXCISION OF MESH IN (B)(6) 2013. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185662 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention