BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3142711 · Received June 3, 2013

    Report

    Report Number
    2210968-2013-06398
    Event Type
    Injury
    Date Received
    June 3, 2013
    Report Date
    May 14, 2013
    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). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED DUE TO STRESS URINARY INCONTINENCE. THE PATIENT EXPERIENCED PAIN, INFECTION, RECURRENCE, DYSPAREUNIA AND URINARY PROBLEMS. ON (B)(6) 2006, THE PATIENT UNDERWENT RELEASE OF MESH DUE TO URGENCY AND INCONTINENCE. THE PATIENT UNDERWENT REMOVAL OF MESH ON RIGHT SIDE DUE TO PAIN ON (B)(6) 2007. THE PATIENT UNDERWENT INTERSTIM PLACEMENT ON (B)(6) 2007 AND REMOVAL ON (B)(6) 2008. THE PATIENT UNDERWENT UTEROSCOPY AND STENT PLACEMENT DUE TO KIDNEY STONE ON (B)(6) 2009 AND REMOVAL ON (B)(6) 2009. THE PATIENT ALSO UNDERWENT ON CYSTOSCOPY WITH URETHRAL DILATION FOR INTERSTITITIAL CYSTITIS ON (B)(6) 2006, (B)(6) 2008, (B)(6) 2009, (B)(6) 2010, (B)(6) 2011, (B)(6) 2012 AND (B)(6) 2013. (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT CYSTOSCOPY AND BOTOX INJECTION ON (B)(6) 2008 DUE TO REFRACTORY URINARY URGENCY AND FREQUENT PELVIC PAIN. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    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) 2003 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT 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
    245002 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 1091615

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention