BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3100066 · Received May 8, 2013

    Report

    Report Number
    2210968-2013-05241
    Event Type
    Injury
    Date Received
    May 8, 2013
    Report Date
    April 15, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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). 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 THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2009 AND MESH WAS IMPLANTED CONCURRENTLY WITH ANTERIOR MESH, DIAGNOSTIC CYSTOSCOPY, KEYES PUNCH BIOPSY OF THE VULVAR SKIN AT THE CHANGE BETWEEN NORMAL AND ABNORMAL SKIN DUE TO VAGINAL VAULT PROLAPSE STATUS POST HYSTERECTOMY, STRESS URINARY INCONTINENCE WITH INTRINSIC SPHINCTERIC DEFICIENCY PRESUMED, LICHENOID DERMATITIS AND SUSPECTED LICHEN SCLEROSIS OF THE VULVA. THE PATIENT UNDERWENT GRAFT REVISION ON (B)(6) 2009 DUE TO GRAFT EROSION/EXTRUSION ON THE ANTERIOR VAGINAL WALL. THE PATIENT UNDERWENT SUR POSTERIOR COLPORRHAPHY, REPAIR OF RECTOCELE AND PERINEORRHAPHY ON (B)(6) 2010. IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR REPAIR WITH GRAFT, MESH EXCISION AND VAGINAL WALL REVISION, CYSTOSCOPY AND REPEAT VULVAR BIOPSY ON (B)(6) 2010. IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXCISION OF MESH CONCURRENTLY WITH ANTERIOR COLPORRHAPHY AND REVISION OF THE VAGINAL WALL MUCOSA USING GRAFT AND CYSTOSCOPY ON (B)(6) 2012.

    Additional Manufacturer Narrative · 1

    (B)(4): IT WAS REPORTED THAT THE PATIENT HAD XENFORM SOFT TISSUE REPAIR ON (B)(6) 2012.

    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 EROSION, BLADDER SPASMS, INCONTINENCE, FORMATION OF SCAR TISSUE, ADDITIONAL SURGERIES AND NEUROLOGIC COMPROMISE TO HER STRUCTURES AND TISSUES. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201485 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 3238430

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention