BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2832159 · Received November 14, 2012

    Report

    Report Number
    2210968-2012-07202
    Event Type
    Injury
    Date Received
    November 14, 2012
    Report Date
    October 24, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, 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.

    Additional Manufacturer Narrative · 1

    THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT DYSFUNCTIONAL UTERINE BLEEDING, PELVIC PAIN, RIGHT PELVIC MASS CONSISTENT WITH HYDROSALPINX AND STRESS URINARY INCONTINENCE. IT WAS REPORTED THAT THE PATIENT HAD A CONCURRENT PROCEDURE OF A LAPARASCOPIC-ASSISTED VAGINAL HYSTERECTOMY WITH RIGHT SALPINGO-OOPHORECTOMY PERFORMED DURING MESH IMPLANTATION. IT WAS NOTED THAT THERE WAS A COMPLICATION DURING SURGERY OF THE PERFORATION OF BLADDER WITH THE RIGHT MESH TROCAR. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4): THE PATIENT UNDERWENT MESH IMPLANTATION WITH THE CONCURRENT PROCEDURES OF LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY AND RIGHT SALPINGO OOPHORECTOMY TO TREAT DYSFUNCTIONAL UTERINE BLEEDING, PELVIC PAIN, RIGHT PELVIC MASS, BLADDER PERFORATION, AND STRESS URINARY INCONTINENCE. IT WAS REPORTED THAT THE PATIENT EXPERIENCED RECURRENCE OF PAIN, INFECTION, URINARY PROBLEMS, AND DYSPAREUNIA. NO ADDITIONAL INFORMATION WAS PROVIDED AT THIS TIME. (B)(4). IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND MESH WAS IMPLANTED CONCURRENTLY WITH HYSTERECTOMY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND A SLING 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
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 2989995

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention