BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2781202 · Received October 10, 2012

    Report

    Report Number
    2210968-2012-06385
    Event Type
    Injury
    Date Received
    October 10, 2012
    Report Date
    September 26, 2012
    Manufacturer
    ETHICON, INC
    Product Code
    FTL
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): IT WAS REPORTED THAT THE PATIENT UNDERWENT SLING IMPLANTATION TO TREAT URINARY INCONTINENCE AND VAGINAL PROLAPSE CONCURRENT WITH ANTERIOR REPAIR AND CYSTOSCOPY. POST IMPLANTATION THE PATIENT EXPERIENCED RECURRENCE OF INCONTINENCE, DYSPAREUNIA, VAGINAL AND ABDOMINAL PAIN.(B)(4).

    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 A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND MESH WAS USED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL TISSUES, AND SHE HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. IT WAS REPORTED THAT THE PATIENT UNDERWENT SLING IMPLANTATION TO TREAT URINARY INCONTINENCE AND VAGINAL PROLAPSE CONCURRENT WITH ANTERIOR REPAIR AND CYSTOSCOPY. POST IMPLANTATION THE PATIENT EXPERIENCED RECURRENCE OF INCONTINENCE, DYSPAREUNIA, VAGINAL AND ABDOMINAL PAIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND MESH WAS USED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL TISSUES, 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
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC NA 3036486

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention