BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2972401 · Received February 21, 2013

    Report

    Report Number
    2210968-2013-01412
    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

    THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT STRESS URINARY INCONTINENCE AND PELVIC ORGAN PROLAPSE. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION, INFECTION, URINARY PROBLEMS, RECURRENCE AND BLEEDING. IT WAS REPORTED THE PATIENT EXPERIENCED MESH EROSION AND RECURRENT STRESS URINARY INCONTINENCE AND UNDERWENT REVISION OF ANTERIOR VAGINAL MESH AND PLACEMENT OF MESH SLING ON (B)(6) 2008. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4). IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. THIS IS ONE OF THREE MEDWATCHES BEING SUBMITTED AS THREE DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2013-26172, AND MEDWATCH 2210968-2013-01417. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF FOUR MEDWATCHES BEING SUBMITTED AS FOUR DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2013-01417 AND MEDWATCH 2210968-2013-26172 AND MEDWATCH 2210968-2014-01148. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    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.IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2013-01417. 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 AN OBTURATOR SLING WAS 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
    75826 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON INC NA 2930751

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention