BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2914035 · Received January 14, 2013

    Report

    Report Number
    2210968-2013-00276
    Event Type
    Injury
    Date Received
    January 14, 2013
    Report Date
    December 21, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K974098
    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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE PATIENT UNDERWENT MESH IMPLANTATION CONCURRENTLY WITH LAPAROSCOPY WITH EXTENSIVE ENTEROLYSIS, LEFT SALPINGOOOPHORECTOMY, TRANSVAGINAL TAPE URETHRAL SLING, AND CYSTOSCOPY. IT WAS REPORTED THAT THE MESH WAS REVISED ON (B)(6) 2005 AND WAS SURGICALLY REMOVED ON (B)(6) 2005 AND ON (B)(6) 2009, DUE TO EROSION, INCONTINENCE, NOCTURIA, AND PAIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL L PROCEDURE ON (B)(6) 2002 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
    20605 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 926093

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention