BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2923783 · Received January 22, 2013

    Report

    Report Number
    2210968-2013-00470
    Event Type
    Injury
    Date Received
    January 22, 2013
    Report Date
    January 2, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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.

    Additional Manufacturer Narrative · 1

    (B)(4): IT WAS REPORTED THAT THE PATIENT UNDERWENT IMPLANT OF MESH DUE TO STRESS INCONTINENCE AND URETHRAL HYPERMOBILITY. EXCISION OF EXPOSED MESH AND REVISION OF VAGINAL SLING WAS PERFORMED ON (B)(6) 2010 DUE TO EROSION. MESH EXCISION WAS PERFORMED ON (B)(6) 2011 DUE TO INCONTINENCE AND TWO AREAS OF EROSION. IT WAS REPORTED THAT THE PATIENT CONTINUES TO EXPERIENCE PAIN, CHRONIC LEAKAGE, LOSS OF BLADDER CONTROL, DYSPAREUNIA, BLEEDING, FREQUENT URINARY TRACT INFECTIONS AND DEVELOPED ALLERGIES TO MEDICATIONS USED TO TREAT COMPLICATIONS OF MESH IMPLANTATION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2005 AND MESH WAS USED. 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
    30152 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 1161800

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention