BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3090397 · Received May 2, 2013

    Report

    Report Number
    2210968-2013-04887
    Event Type
    Injury
    Date Received
    May 2, 2013
    Report Date
    April 9, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K012628
    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 AND MESH WAS IMPLANTED CONCURRENTLY WITH LAPAROSCOPIC RSO. IT WAS REPORTED THAT THE PATIENT UNDERWENT VAGINAL RECONSTRUCTION IN (B)(6) 2010, CHOLECYSTECTOMY IN (B)(6) 2010 & HYDRODISTENTION OF THE BLADDER IN (B)(6) 2011.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH ANTERIOR COLPORRHAPHY, TRANSVAGINAL URETHROLYSIS, CYSTOSCOPY; DUE TO STRESS URINARY INCONTINENCE, AND CYSTOCELE . IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED SEVERE BACK PAIN, VAGINAL BLEEDING, CHRONIC URINARY TRACT INFECTIONS, PAIN IN THE RIGHT LEG, DYSPAREUNIA, EROSION INTO THE BLADDER, INCONTINENCE, PAIN WITH URINATION, BLADDER DYSFUNCTION RESULTING IN THE NEED FOR AN INTERSTIM TO ASSIST WITH URINATION, SEVERE DEPRESSION AND ANXIETY. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REVISION/REMOVAL ON (B)(6) 2011 DUE TO, EXTREME PAIN, INFECTION AND EROSION OF MESH INTO BLADDER AND ON (B)(6) 2012 DUE TO, EXTREME PAIN CAUSED BY THE MESH IMPLANT. (B)(4) - URINARY PROBLEMS.

    Additional Manufacturer Narrative · 1

    (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

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED VAGINAL DISCHARGE. (B)(4).

    Additional Manufacturer Narrative · 1

    (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 IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL TISSUES, AND SHE HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191924 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 1190695

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention