BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2971627 · Received February 21, 2013

    Report

    Report Number
    2210968-2013-01268
    Event Type
    Injury
    Date Received
    February 21, 2013
    Report Date
    January 28, 2013
    Manufacturer
    ETHICON INC
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH POSTERIOR REPAIR AND CYSTOSCOPY; DUE TO RECURRENT GRADE 3 RECTOCELE.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2009 AND MESH WAS IMPLANTED CONCURRENTLY WITH SYS REPAIR APICAL AND IMPLANTATION OF THE POST.

    Additional Manufacturer Narrative · 1

    (B)(6). 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

    ADDITIONAL NARRATIVE: IT WAS REPORTED THAT PATIENT UNDERWENT POSTERIOR REPAIR WITH PELVISOFT GRAFT AND CYSTOURETHROSCOPY ON (B)(6) 2006 BY DR. (B)(6) AT (B)(6) MEDICAL CENTER ((B)(6)) DUE TO GRADE III SYMPTOMATIC RECTOCELE. IT WAS REPORTED THAT PATIENT UNDERWENT ANTERIOR REPAIR WITH AVAULTA GRAFT, TVT-SECUR PROCEDURE AND CYSTOURETHROSCOPY ON (B)(6) 2006 BY DR. (B)(6) AT (B)(6) MEDICAL CENTER DUE TO GRADE III CYSTOCELE AND SUI. IT WAS REPORTED THAT PATIENT UNDERWENT INTERSTIM STAGE I AND STAGE II COMPLETE ON (B)(6) 2014 BY DR. (B)(6) DUE TO URINARY URGENCY, FREQUENCY AND URGE INCONTINENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2009 AND AN OBTURATOR SLING AND ELEVATE WERE IMPLANTED. THE PATIENT EXPERIENCED MULTIPLE COMPLICATIONS, INCLUDING EROSION, FORMATION OF SCAR TISSUE, ADDITIONAL SURGERIES AND NEUROLOGIC COMPROMISE TO HER STRUCTURES AND TISSUES. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76802 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON INC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention