BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2981362 · Received February 27, 2013

    Report

    Report Number
    2210968-2013-01881
    Event Type
    Injury
    Date Received
    February 27, 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
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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 MEDWATCH 2210968-2012-02073 . THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ON (B)(6) 2005. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, DYSURIA, HEMATURIA, EXTRUSION, URINARY/BOWEL PROBLEMS, RIGHT GROIN PAIN, AND BLEEDING. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REVISION (PUBOVAGINAL SLING AND EXCISION OF EXPOSED VAGINAL MESH) ON (B)(6) 2012 DUE TO ABDOMINAL PAIN, PAINFUL URINATION, MESH EXPOSURE, BLEEDING, AND EROSION. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4): THE PATIENT UNDERWENT MESH IMPLANTATION CONCURRENTLY WITH LAPAROSCOPIC HYSTERECTOMY/ BILATERAL SALPINGO-OOPHORECTOMY, AND ANTERIOR REPAIR. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE TO TREAT STRESS URINARY INCONTINENCE ON (B)(6) 2005 AND AN OBURATOR SLING WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, BLEEDING, VAGINAL SPOTTING, AND THE FEELING OF URGENCY TO URINATE. SHE WAS DIAGNOSED WITH MESH EROSION AND THE MESH WAS REMOVED ON (B)(6) 2012. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85393 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 1282680

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention