BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3091031 · Received May 3, 2013

    Report

    Report Number
    2210968-2013-04903
    Event Type
    Injury
    Date Received
    May 3, 2013
    Report Date
    April 9, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2001 AND MESH WAS IMPLANTED DUE TO STRESS URINARY INCONTINENCE. THE PATIENT UNDERWENT MESH REVISION ON (B)(6) 2003 DUE TO EROSION OF VAGINAL MESH INTO THE ANTERIOR VAGINAL MUCOSA. IT WAS REPORTED THAT THE PATIENT WAS TREATED ON (B)(6) 2003 FOR EROSION OF MESH IN THE ANTERIOR MUCOSA AND DYSPAREUNIA. THE PATIENT WAS TREATED ON (B)(6) 2013 FOR VAGINAL EROSION, URINARY INCONTINENCE AND DYSPAREUNIA.

    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 THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2001 AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL TISSUES, AND SHE HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195308 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 634731

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention