BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3072413 · Received April 23, 2013

    Report

    Report Number
    2210968-2013-04270
    Event Type
    Injury
    Date Received
    April 23, 2013
    Report Date
    April 3, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - MESH EXPOSURE . 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 HYSTERECTOMY WITH BLADDER RECONSTRUCTION IN (B)(6) 2008 AND AN OBTURATOR SLING WAS IMPLANTED. THE PATIENT WAS HAVING THE HYSTERECTOMY AND AN UROLOGIST WAS CONSULTED, WHO STATED SHE NEEDED THE RECONSTRUCTION BUT THE PATIENT DENIED HAVING ANY URINARY ISSUES AT THAT TIME. AT THE END OF 2009 OR THE BEGINNING OF 2010, THE PATIENT STARTED TO HAVE URINARY TRACT INFECTIONS AND WAS TOLD BY A PHYSICIAN THAT IT MAY BE RELATED TO THE MESH. A MESH EROSION WAS SEEN BY A PHYSICIAN IN (B)(6) 2011. THE PATIENT REPORTED THAT SHE NEEDS AN ADDITIONAL SURGERY TO REMOVE THE MESH DUE TO THE EROSION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173489 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 3105396

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention