BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3111884 · Received May 14, 2013

    Report

    Report Number
    2210968-2013-05517
    Event Type
    Injury
    Date Received
    May 14, 2013
    Report Date
    April 25, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: 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 BY THE PATIENT THAT SHE UNDERWENT A SLING PROCEDURE ON AN UNKNOWN DATE. THE PATIENT REPORTED THAT SHE HAS HAD 26 SURGERIES PRIOR TO THE PLACEMENT OF THE DEVICE. SHE STATED THAT SHE HAS LOST A PORTION OF HER BOWEL AND ARTERY DUE TO DIFFERENT MESHES. THE PATIENT STATED THAT HER BLADDER EMPTIES ON ITS OWN. THE PATIENT REPORTED THAT HER SPOUSE CAN FEEL SOMETHING DURING INTERCOURSE. SHE EXPERIENCED INTERMITTENT BLEEDING. THE PATIENT HAS BEEN SEEN BY HER GYNECOLOGIST AND HAS BEEN REFERRED TO A UROLOGIST, WHOM SHE WILL BE SEEING IN A COUPLE OF WEEKS. THE PATIENT REPORTED THAT IMMEDIATELY AFTER THE MESH WAS PLACED, SHE EXPERIENCED A WOUND DEHISCENSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213605 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention