BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2992813 · Received March 7, 2013

    Report

    Report Number
    2210968-2013-02197
    Event Type
    Injury
    Date Received
    March 7, 2013
    Report Date
    February 15, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    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): 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. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    \IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2011 AND MESH WAS IMPLANTED CONCURRENTLY WITH CYSTOSCOPY DUE TO URETHRAL HYPERMOBILITY WITH STRESS URINARY INCONTINENCE. IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE ON (B)(6) 2009 FOR AN OPERATIVE LAPAROSCOPY AND LYSIS OF ADHESIONS DUE TO PELVIC PAIN. AND ON (B)(6) 2009, SHE UNDERWENT LYSIS OF ADHESIONS AND VAGINAL RESECTION OF VAGINAL CUFF CORNER DUE TO PELVIC PAIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2011 AND MESH WAS USED. THE PATIENT EXPERIENCED PAIN, MESH EROSION, INFECTION, BLEEDING, VAGINAL SCARRING/SHRINKAGE AND EXPOSURE/EXTRUSION/PROTRUSION, 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
    96846 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 3473759

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention