BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3031196 · Received April 2, 2013

    Report

    Report Number
    2210968-2013-03092
    Event Type
    Injury
    Date Received
    April 2, 2013
    Report Date
    March 15, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH CYSTOSCOPY DUE TO SECOND-DEGREE CYSTOCELE. IT WAS REPORTED THAT PATIENT UNDERWENT RESECTION OF MESH, VAGINOPLASTY AND CYSTOSCOPY ON (B)(6) 2010 DUE TO PELVIC PAIN, DYSPAREUNIA AND MESH EROSION INTO VAGINA.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE IN ORDER TO TREAT STRESS URINARY INCONTINENCE AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT HAD A CONCURRENT PROCEDURE OF A HYSTERECTOMY PERFORMED DURING MESH IMPLANTATION. IT WAS ALSO REPORTED THAT FOLLOWING INSERTION OF THE MESH, THE PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION, INFECTION, URINARY PROBLEMS, RECURRENCE, DYSPAREUNIA AND VAGINAL SCARRING. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REVISION AND CYSTECTOMY ON (B)(6) 2007 DUE TO PAINFUL INTERCOURSE AND ON (B)(6) 2009, UNDERWENT RESECTION OF THE MESH TAPE, VAGINOPLASTY AND EXTESCOPY DUE TO EROSION OF THE MESH TAPE INTO THE VAGINAL MUCOSA AND DYSPAREUNIA . NO ADDITIONAL INFORMATION WAS PROVIDED. (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

    RESUBMISSION WITH THE CORRECT FILE NUMBER. DATE SENT TO THE FDA: 01/25/2017. IT WAS REPORTED THAT PATIENT UNDERWENT TVT REVISION ON (B)(6) 2008 BY AT (B)(6) DUE TO HISTORY OF TVT WITH TISSUE EROSION AND EXPOSED MESH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND A SLING WAS IMPLANTED. 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
    134588 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 3016486

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention