BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3150367 · Received June 6, 2013

    Report

    Report Number
    2210968-2013-06693
    Event Type
    Injury
    Date Received
    June 6, 2013
    Report Date
    May 14, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT REPAIR OF MULTIPLE ENTEROSTOMIES, EXCISION OF MARLEX MESH, EXTENSIVE LYSIS OF ADHESIONS, REMOVAL OF TWO THIRDS OF MESH FROM PREVIOUS SACRAL COLPOPEXY WITH REPLACEMENT GRAFTS FOR SACRAL COLPOPEXY, CYSTOURETHROSCOPY, OMENTAL J-FLAP AND INCISION OF PREVIOUS VULVAR INCISION WITH EXPLORATION AND CLOSURE ON (B)(6) 2006. (B)(4).

    Additional Manufacturer Narrative · 1

    THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT STRESS URINARY INCONTINENCE, FREQUENCY, URGENCY, INCOMPLETE UTEROVAGINAL PROLAPSE, LARGE CYSTOCELE, AND MILD RECTOCELE. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, URINARY PROBLEMS, NEUROMUSCULAR PROBLEMS, VAGINAL SCARRING, ORGAN PERFORATION AND OTHER NON- SPECIFIED OUTCOMES. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT REPAIR OF MULTIPLE ENTEROSTOMIES DUE TO EXCISION OF MARLEX MESH ON (B)(6) 2006 AND EXTENSIVE LYSIS OF ADHESIONS, REMOVAL OF TWO THIRDS OF THE GRAFT FROM PREVIOUS SACRAL COLPOPEXY WITH REPLACEMENT GRAFTS FOR SACRAL COLPOPEXY, CYSTOURETHROSCOPY, OMENTAL J-FLAP, INCISION OF PREVIOUS VULVAR INCISION WITH EXPLORATION AND CLOSURE.

    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 THE PATIENT UNDERWENT A GYNECOLOGICAL ON (B)(6) 2010 AND MESH WAS IMPLANTED INTO THE PATIENT. IT IS REPORTED THAT 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
    251400 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention