BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLENE MESH

    MDR report key: 3022634 · Received March 16, 2013

    Report

    Report Number
    3022634
    Event Type
    Malfunction
    Date Received
    March 16, 2013
    Date of Event
    February 4, 2013
    Report Date
    March 11, 2013
    Manufacturer
    ETHICON ENDO-SURGERY
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ERODED VAGINAL MESH. PATIENT IS STATUS POST-VAGINAL HYSTERECTOMY AND ROBOTIC SACROCOLPOPEXY AT AN OUTSIDE INSTITUTION. SHE ALSO HAD A TRANSOBTURATOR TAPE PLACED. FOLLOWING THAT SURGERY, SHE HAD PERSISTENT VAGINAL PAIN AND MESH EROSION. SHE HAD BEEN TAKEN TO THE OPERATING ROOM ON 2 OCCASIONS AT THE OUTSIDE INSTITUTION 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 6 CENTIMETER LINE DOWN THE ANTERIOR VAGINAL WALL THAT WAS OVER ON THE PATIENT'S RIGHT SIDE WITH A RIDGE AND FIBERS OF THE MESH THAT WERE EXPOSED. AT THE APEX, THERE WAS A LARGER PIECE ABOUT 1 CENTIMETER EXPOSURE OF MESH.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?EXCISION OF VAGINAL MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111166 PROLENE MESH MESH, SURGICAL, POLYMERIC FTL ETHICON ENDO-SURGERY UNK *

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR