BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2913413 · Received January 14, 2013

    Report

    Report Number
    2210968-2013-00275
    Event Type
    Injury
    Date Received
    January 14, 2013
    Report Date
    December 17, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K100936
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: IT WAS REPORTED THAT ON (B)(6) 2011 THE PATIENT UNDERWENT MESH REVISION AND EXCISION ALONG WITH THE CONCURRENT PROCEDURES OF DEBRIDEMENT, ANTERIOR URETHROPEXY, AND CYSTOSCOPY.

    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. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2012-06255. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    (B)(4). IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT VAGINAL PROLAPSE WITH CYSTOCELE AND RECTOCELE, AND STRESS URINARY INCONTINENCE. IT WAS REPORTED THAT THE PATIENT HAD A CONCURRENT PROCEDURE OF AN ANTERIOR URETHROPOPEXY, ANTERIOR PROXIMAL COLPORRHAPHY WITH POSTERIOR PROXIMAL COLPORRHAPHY AND CYSTOURETHROSCOPY PERFORMED DURING MESH IMPLANTATION. IT WAS REPORTED THAT THE PATIENT UNDERWENT EXCISION AND DEBRIDEMENT OF VAGINAL MESH ON (B)(6) 2011 ALONG WITH ANTERIOR URETHROPEXY AND CYSTOSCOPY, DUE TO VAGINAL EROSION WITH URINARY INCONTINENCE. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED WORSENING INCONTINENCE, PAINFUL INTERCOURSE, AND SCAR TISSUE.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RECTAL EXAM UNDER ANESTHESIA, A LATERAL SPHINCTEROTOMY, AND AN EXCISION OF EXTERNAL TAG ON (B)(6) 2012 DUE TO ANORECTAL PAIN AND AN ANAL FISSURE. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH IMPLANT REMOVAL ON (B)(6) 2013 BY(B)(6) DUE TO EROSION OF IMPLANTED VAGINAL MESH AND OTHER PROSTHETIC MATERIALS TO SURROUNDING ORGAN OR TISSUE, DYSPAREUNIA AND MIXED STRESS AND URGE INCONTINENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2010 AND A SLING WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES, 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
    20304 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 3460717

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention