BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3020527 · Received March 26, 2013

    Report

    Report Number
    2210968-2013-02762
    Event Type
    Injury
    Date Received
    March 26, 2013
    Report Date
    March 6, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT EXPERIENCED VAGINAL MESH EXTRUSION WITH EXTENSIVE VAGINAL WALL GRANULATION TISSUE FORMATION ON (B)(6) 2007. THE PATIENT UNDERWENT ILIOINGUINAL NERVE BLOCK WITH NERVE STIMULATOR GUIDANCE ON (B)(6) 2011. THE PATIENT UNDERWENT EXCISION OF ANTERIOR VAGINAL WALL MESH, ANTERIOR COLPORRHAPHY, CYSTOURETHROSCOPY, RELEASE OF VAGINAL STRICTURE, AND PERINEOPLASTY ON (B)(6) 2012. (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. 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) 2007 AND MESH WAS IMPLANTED CONCURRENTLY WITH CYSTOCELE/RECTOCELE REPAIR AND URINE INCONTINENCE REPAIR DUE TO CYSTOCELE, MIDLINE, VAGINAL WALL PROLAPSE, AND FEMALE STRESS INCONTINENCE.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND MESH WAS IMPLANTED DUE TO UTERINE PROLAPSE. THE PATIENT UNDERWENT MESH REVISION/REMOVAL ON (B)(6) 2007 AND (B)(6) 2008. IT WAS ALSO REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE ON (B)(6) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2007 AND MESH AND BARD PELVISOFT ACELLULAR COLLAGEN BIOMESH WERE IMPLANTED. IT WAS REPORTED THAT SHE 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
    123403 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 2982451

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention