BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3100067 · Received May 8, 2013

    Report

    Report Number
    2210968-2013-05082
    Event Type
    Injury
    Date Received
    May 8, 2013
    Report Date
    April 16, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K100485
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION, BLEEDING, INFECTION, RECURRENCE, DYSPAREUNIA, ORGAN PERFORATION AND CYSTITIS CYSTIC. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REVISION/RELEASE AND CYSTOSCOPY ON (B)(6) 2011. THE PATIENT UNDERWENT TRANSVAGINAL REMOVAL OF MESH WITH REMOVAL OF URETHRAL MESH, CLOSURE OF THE URETHRA AND CYSTOSCOPY ON (B)(6) 2011 DUE TO STRESS URINARY INCONTINENCE AND MESH EROSION INTO THE URETHRA WITH BLADDER OUTLET OBSTRUCTION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). 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) 2011 AND MESH WAS IMPLANTED INTO THE PATIENT. 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
    201936 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention