BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2881323 · Received December 20, 2012

    Report

    Report Number
    2210968-2012-08163
    Event Type
    Injury
    Date Received
    December 20, 2012
    Report Date
    December 1, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K100485
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTED NARRATIVE: IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE IN ORDER TO TREAT URINARY FREQUENCY, URINARY INCONTINENCE, URINATION PAIN, AMENORRHEA, AND A WEAK BLADDER WITH LEAKING AND NO CONTROL ON (B)(6) 2001 AND MESH WAS USED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. THE PATIENT REPORTED EROSION, INFECTION, URINARY PROBLEMS, FISTULA, RECURRENCE, AND VAGINAL SCARRING AS OUTCOMES FOLLOWING MESH IMPLANTATION. IT WAS REPORTED THAT THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. THE PATIENT UNDERWENT MESH EXPLANTATION/REVISION ON (B)(6) 2010 DUE TO A MESH INDUCED FISTULA IN THE BLADDER NECK. THE PATIENT UNDERWENT MESH EXPLANTATION/REVISION ALONG WITH THE CONCURRENT PROCEDURE OF AN URETHROVAGINAL FISTULA REPAIR WITH MESH REMOVAL ON (B)(6) 2011 DUE TO A MESH INDUCED FISTULA AND SCARRING. THE PATIENT UNDERWENT MESH EXPLANTATION/REVISION ALONG WITH THE CURRENT PROCEDURES OF AUTOLOGOUS FACIA PUBOVAGINAL MESH, REPAIR OF AN URETHRO-VAGINAL FISTULA, GRAFT (ILLEGIBLE), AND INTERPOSITION WITH CYSTOSCOPY (NO IMPLANT) ON (B)(6) 2011 DUE TO URINARY INCONTINENCE, A URETHRAL FISTULA AND MESH EROSION. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4) - URINARY PROBLEMS; UNDEFINED RECURRENCE.

    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.IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    DATE SENT TO FDA: 04/13/2017.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2010 AND MESH WAS USED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 3447680

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention