BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2831799 · Received November 14, 2012

    Report

    Report Number
    2210968-2012-07160
    Event Type
    Injury
    Date Received
    November 14, 2012
    Report Date
    October 23, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2006 AND MESH WAS IMPLANTED DUE TO STRESS URINARY INCONTINENCE. THE PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION, INFECTION, AND URINARY PROBLEMS. THE PATIENT UNDERWENT MESH REVISION WITH EXCISION OF ABDOMINAL KELOID SCAR ON (B)(6) 2006 DUE TO PAIN AND EROSION OF MESH SUBURETHRALLY. ON (B)(6) 2007, THE PATIENT HAD A SPARC SLING SYSTEM (AMS) IMPLANTED DUE TO STRESS URINARY INCONTINENCE. (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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2006 AND A SLING AND SPARC PUBO VAGINAL SLING (AMS) WERE IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 1335104

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention