BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3020836 · Received March 26, 2013

    Report

    Report Number
    2210968-2013-02813
    Event Type
    Injury
    Date Received
    March 26, 2013
    Report Date
    March 7, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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. 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 2210968-2013-02810 AND MEDWATCH 2210968-2013-02816. 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) 2006 IN ORDER TO TREAT RECURRENT STRESS INCONTINENCE AND MESH EROSION. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH TRIM REVISION ON (B)(6) 2007. IT WAS REPORTED THAT THE PATIENT UNDERWENT ANTERIOR REPAIR, UTEROSACRAL LIGAMENT COLPOPEXY, CYSTOSCOPY, BLADDER SUSPENSION, AND RECTOCELE REPAIR ON (B)(6) 2008. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT HAD A VAGINAL EXCISIONAL BIOPSY, FOREIGN BODY GIANT CELL REACTION, AND FIBROSIS ASSOCIATED WITH FOREIGN MATERIAL CONSISTENT WITH MESH DATED (B)(6) 2008. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT STRESS URINARY INCONTINENCE, UTERINE ORGAN PROLAPSE AND A CYSTOCELE. THE PATIENT UNDERWENT THE CONCOMITANT PROCEDURE OF A TOTAL VAGINAL HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY AND POSTERIOR REPAIR COLPORRHAPHY DURING MESH IMPLANTATION. IT WAS REPORTED THAT THE PATIENT UNDERWENT A MESH REMOVAL ON (B)(6) 2006 AND (B)(6) 2006.

    Additional Manufacturer Narrative · 1

    (B)(4)

    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 HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124402 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 1392078

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention