BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3151963 · Received June 7, 2013

    Report

    Report Number
    2210968-2013-06721
    Event Type
    Injury
    Date Received
    June 7, 2013
    Report Date
    April 23, 2018
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    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). 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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY ON (B)(6) 2006 TO TAKE DOWN PREVIOUSLY PLACED MESH DUE TO INCONTINENCE. IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY (B)(6) 2007 FOR A TRANSVAGINAL INCISION AND EXCISION OF SUBURETHRAL TRANSVAGINAL TAPE DUE TO COMPLETE OUTFLOW OBSTRUCTION FROM TRANSVAGINAL TAPE-- STATUS POST PRIOR TO ABDOMINAL RELEASE OF TRANSVAGINAL TAPE. NO ADDITIONAL INFORMATION WAS PROVIDED. (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 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
    253303 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 1309422

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention