BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3023971 · Received March 27, 2013

    Report

    Report Number
    2210968-2013-02722
    Event Type
    Injury
    Date Received
    March 27, 2013
    Report Date
    March 4, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR VAGINAL REPAIR WITH LEVATOR PLICATION AND PERINEOPLASTY ON (B)(6) 2013 DUE TO CYSTOCELE, RECTOCELE AND UTERINE PROLAPSE.

    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

    (B)(4): THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT STRESS URINARY INCONTINENCE. THE PATIENT UNDERWENT THE CONCURRENT PROCEDURE OF PERNEORRHAPHY DURING MESH IMPLANTATION. THE OUTCOMES ATTRIBUTED TO THE DEVICE WERE PAIN, DYSPAREUNIA, BLEEDING FOLLOWING INTERCOURSE, FOUL ODOR, EROSION, EXPOSURE, AND PARTNER SCRATCHED DURING INTERCOURSE. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2012.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2008 AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED MULTIPLE COMPLICATIONS, INCLUDING EROSION, 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
    126699 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON INC. NA 3171173

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention