BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3061735 · Received April 16, 2013

    Report

    Report Number
    2210968-2013-03939
    Event Type
    Injury
    Date Received
    April 16, 2013
    Report Date
    March 27, 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).

    Additional Manufacturer Narrative · 1

    THE PATIENT UNDERWENT MESH IMPLANTATION ON (B)(6) 2009 DUE TO STRESS URINARY INCONTINENCE. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EXTRUSION, URINARY PROBLEMS, BLEEDING, RECURRENCE AND VAGINAL SCARRING. IT WAS REPORTED THAT PATIENT EXPERIENCED PULLING AND PAIN ON LEFT SIDE AND UNDERWENT MESH REVISION IN (B)(6) 2010 AND THEN UNDERWENT REMOVAL IN (B)(6) 2012. (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2009 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT AUTOLOGOUS FASCIA PUBOVAGINAL SLING, CYSTOSCOPY, AND EXCISION OF LEFT VAGINAL SCAR AND GRANULATION TISSUE ON (B)(6) 2012 DUE TO RECURRENT STRESS URINARY INCONTINENCE AND LEFT VAGINAL AND PELVIC PAIN. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4): IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH A CYSTOSCOPY DUE TO STRESS URINARY INCONTINENCE, CYSTOCELE, AND RECTOCELE. THE PATIENT UNDERWENT MESH RELEASE (B)(6) 2010. IT WAS REPORTED THAT THE PATIENT UNDERWENT EXCISION OF ANTERIOR MESH, PLACEMENT OF ANTERIOR REPLIFORM GRAFT AND CYSTOSCOPY ON (B)(6) 2012 DUE TO ANTERIOR MESH PAIN.

    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. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2013-03944. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2009 AND MESH 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
    163392 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 3002987

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention