BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2800427 · Received October 22, 2012

    Report

    Report Number
    2210968-2012-06797
    Event Type
    Injury
    Date Received
    October 22, 2012
    Report Date
    October 15, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K033568
    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 TO TREAT STRESS URINARY INCONTINENCE, RECTOCELE AND AN OBTURATOR SLING WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT MESH REMOVAL DUE TO EROSION, PAIN, INFECTIONS AND BLEEDING ON (B)(6) 2011 AT IMPLANTING FACILITY AND SURGEON. PATIENT ALSO UNDERWENT PELVIC FLOOR REPAIR WITH RECTOCELE IN (B)(6) 2010 AT IMPLANTING FACILITY. (B)(4).

    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

    THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT STRESS URINARY INCONTINENCE. THE PATIENT UNDERWENT THE CONCURRENT PROCEDURES OF RECTOCELE REPAIR DURING MESH IMPLANTATION. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED MESH EROSION, INFLAMMATION, VAGINAL PAIN, BLADDER PAIN, PELVIC PAIN, ABDOMINAL PAIN, DYSPAREUNIA, BLEEDING AFTER INTERCOURSE, CHRONIC DISCHARGE, BLOATING, CHRONIC BLADDER INFECTIONS, URINARY TRACT INFECTIONS, CHRONIC YEAST INFECTIONS, DIFFICULTY WITH URINATION, URINE LEAKAGE, AND MANUAL ASSIST WITH BOWEL MOVEMENTS. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2008 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 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention