BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3142072 · Received June 3, 2013

    Report

    Report Number
    2210968-2013-06344
    Event Type
    Injury
    Date Received
    June 3, 2013
    Report Date
    May 6, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2013-06345. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: THE PATIENT UNDERWENT ANTERIOR/POSTERIOR ¿MESH TOTAL PELVIC RECONSTRUCTION¿ [AS WRITTEN] DUE TO PELVIC ORGAN PROLAPSE ON (B)(6) 2006. THE PATIENT CONTINUED TO HAVE PERSISTENT STRESS URINARY INCONTINENCE, URETHRAL INCOMPETENCE AND GROSS HEMATURIA. THE PATIENT HAD A CYSTOSCOPY ON (B)(6) 2007. THE PATIENT EXPERIENCED EROSION OF RECTOCELE MESH AND UNDERWENT CYSTOSCOPY AND A TRANSURETHRAL CONTIGEN INJECTION ON (B)(6) 2008. THE PATIENT UNDERWENT MESH REVISION/REMOVAL ON (B)(6) 2011 AND UNDERWENT REMOVAL OF MESH AND CYSTOSCOPY ON (B)(6) 2012 DUE TO MESH EROSION/EXTRUSION, PELVIC PAIN, AND VAGINAL DISCHARGE. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4) - URETHRAL INCOMPETENCE. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2013-06345. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2006 AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF INTERNAL BODILY TISSUE, EXTRUSION, INFECTION, RECURRENCE, BLEEDING, DYSPAREUNIA, VAGINAL SCARRING, ORGAN PERFORATION AND OTHER INJURIES FOLLOWING THE PROCEDURE. IT WAS ALSO REPORTED THAT THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. THE PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2012 DUE TO EROSION OF THE MESH. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244942 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention