BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2760480 · Received September 26, 2012

    Report

    Report Number
    2210968-2012-05563
    Event Type
    Injury
    Date Received
    September 26, 2012
    Report Date
    September 4, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ON (B)(6) 2010. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED CHRONIC PELVIC AND VAGINAL AREA PAIN, PAINFUL INTERCOURSE, CHRONIC PAIN WITH SITTING AND STANDING, BOWEL PROBLEMS WITH FECAL INCONTINENCE, VAGINAL SCARRING/SHRINKING, AND NERVE DAMAGE. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT SLING IMPLANTATION TO TREAT PELVIC ORGAN PROLAPSE AND STRESS URINARY INCONTINENCE. POST IMPLANTATION THE PATIENT EXPERIENCED PAIN, DYSPAREUNIA, SCARRING, NERVE DAMAGE, HYPERTENSION AND BOWEL PROBLEMS. (B)(4).

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: (B)(4) 2012. (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    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 ON (B)(6) 2010 AND MESH WAS USED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE, URINARY TRACT INFECTIONS 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
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 3422082

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention