BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2946128 · Received February 6, 2013

    Report

    Report Number
    2210968-2013-00808
    Event Type
    Injury
    Date Received
    February 6, 2013
    Report Date
    January 14, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A VAGINAL HYSTERECTOMY, ANTERIOR REPAIR WITH AN ADDITIONAL IMPLANTED MESH AND CYSTOSCOPY ON (B)(6) 2008 DUE TO UTERINE PROLAPSE ASSOCIATED WITH A LARGE CYSTOCELE AND MENORRHAGIA. IT WAS REPORTED THAT THE PATIENT UNDERWENT EXCISION AND REPAIR OF ERODED ANTERIOR MESH ON (B)(6) 2012 DUE TO MESH EROSION, STRESS URINARY INCONTINENCE AND PAIN. IN ADDITION TO THIS PROCEDURE, THE PATIENT HAD TWO ADDITIONAL MESHES IMPLANTED ON (B)(6) 2012. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4). THIS IS ONE OF FOUR MEDWATCHES BEING SUBMITTED AS FOUR DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2013-18474, MEDWATCH 2210968-2013-12755, AND MEDWATCH 2210968-2013-12757. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT ON (B)(6) 2004 THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE IN ORDER TO TREAT STRESS URINARY INCONTINENCE AND CYSTOCELE AND MESH WAS IMPLANTED ALONG WITH THE CONCURRENT PROCEDURE OF CYSTOSCOPY. IT WAS REPORTED THAT FOLLOWING INSERTION OF THE MESH THE PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION, URINARY/BOWEL PROBLEMS, ORGAN PERFORATION, RECURRENCE, DYSPAREUNIA AND NEUROMUSCULAR PROBLEMS. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REVISION ON (B)(6) 2012 DUE TO VAGINAL CUFF PROLAPSED WITH PRESSURE WITH ENTEROCELE, POSTERIOR RECTOCELE AND LOSS OF PERINEAL MUSCULATURE SUPPORT, SUI, FAILED PRIOR SLING PROCEDURE, AND EROSION FROM PRIOR ANTERIOR REPAIR. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2004 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 ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50894 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 1125012

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention