BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3080865 · Received April 26, 2013

    Report

    Report Number
    2210968-2013-04555
    Event Type
    Injury
    Date Received
    April 26, 2013
    Report Date
    April 1, 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). 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. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2013-04554. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT STRESS URINARY INCONTINENCE AND SYMPTOMATIC UTERINE FIBROIDS. IT WAS REPORTED THAT THE PATIENT HAD THE CONCURRENT PROCEDURES OF A LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY PERFORMED DURING MESH IMPLANTATION. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REVISION ON (B)(6) 2009 DUE TO VAGINAL MESH EXPOSURE. THE PATIENT UNDERWENT A SECOND MESH IMPLANTATION ON (B)(6) 2011 IN ORDER TO TREAT CYCLIC VAGINAL BLEEDING, EXPOSED VAGINAL MESH, DYSPAREUNIA, AND MIXED INCONTINENCE. DURING THIS SECOND IMPLANTATION IT WAS REPORTED THAT THE PATIENT HAD THE CONCURRENT PROCEDURES OF AN EXCISION OF EXPOSED VAGINAL MESH, MESH, CYSTOSCOPY AND LAPAROSCOPIC TRACHELECTOMY PERFORMED DURING MESH IMPLANTATION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2009 AND MESH WAS IMPLANTED. IT IS REPORTED THAT 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
    182469 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 3195455

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention