BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2931283 · Received January 28, 2013

    Report

    Report Number
    2210968-2013-00554
    Event Type
    Injury
    Date Received
    January 28, 2013
    Report Date
    January 11, 2013
    Manufacturer
    ETHICON. INC.
    Product Code
    FTL
    PMA / PMN Number
    K052401
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. SEE ALSO MEDWATCH 2210968-2013-00553. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH. 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). THE PATIENT UNDERWENT MESH IMPLANTATION CONCURRENTLY WITH VAGINAL HYSTERECTOMY DUE TO STRESS URINARY INCONTINENCE AND PELVIC ORGAN PROLAPSE. IT WAS REPORTED THAT PATIENT EXPERIENCED BLEEDING, DYSPAREUNIA, VAGINAL PAIN AND URINARY INCONTINENCE POST IMPLANTATION. IT WAS ALSO REPORTED THAT DUE TO MESH EROSION, PATIENT UNDERWENT MESH REMOVAL BY IMPLANTING SURGEON IN (B)(6) 2008. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED. SEE ALSO MEDWATCH 2210968-2013-00553. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT MESH REVISION ON (B)(6) 2009 BY DR. (B)(6) DUE TO MESH EROSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2008 AND MESH WAS USED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES, AND SHE HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT MESH REVISION ON (B)(6) 2009 BY DR. (B)(6) DUE TO MESH EROSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37281 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON. INC. NA 3081328

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention