BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2754596 · Received September 21, 2012

    Report

    Report Number
    2210968-2012-05546
    Event Type
    Injury
    Date Received
    September 21, 2012
    Report Date
    August 29, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT STRESS URINARY INCONTINENCE, PELVIC ORGAN PROLAPSE, PELVIC PAIN, AND RIGHT LOWER QUADRANT PAIN. THE PATIENT UNDERWENT THE CONCURRENT PROCEDURES OF LAPAROSCOPY, LYSIS OF ADHESIONS, DRAINAGE AND EXCISION OF LEFT OVARIAN CYST, DISSECTION OF ENTRAPPED RIGHT OVARY, AND CYSTOSCOPY WITH HYDRODISTENTION OF THE BLADDER FOR THE DIAGNOSIS OF INTERSTITIAL CYSTITIS. THE POST OP DIAGNOSIS WAS DENSE FIBROTIC PELVIC ADHESIONS AROUND RIGHT OVARY, MULTIPLE BOWEL EPIPLOIC ADHESIONS TO VAGINAL CUFF AND LEFT OVARY, LEFT OVARY WITH LEFT DENSE ADHESIONS AND 4CM SIMPLE CYST, HYPER PETECHIAL REACTION TO HYDRODISTENSION OF THE BLADDER INDICATIVE OF INTERSTITIAL CYSTITIS, AND POSSIBLE ENDOMETRIOSIS OF THE POSTERIOR CUL DE SAC. HEPATIC ADHESIONS ARE SOMETIMES SEEN WITH FITZ-HUGH-CURTIS SYNDROME. (B)(4) - CYST; ENDOMETRIOSIS; FITZ-HUGH-CURTIS SYNDROME.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT SLING IMPLANTATION TO TREAT PELVIC ORGAN PROLAPSE. POST IMPLANTATION THE PATIENT EXPERIENCED ABDOMINAL PAIN, DYSPAREUNIA AND URINARY INCONTINENCE. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2011 AND MESH WAS IMPLANTED DUE TO STRESS URINARY INCONTINENCE, CYSTOCELE, AND CYSTITIS. THE PATIENT EXPERIENCED PAIN, URINARY PROBLEMS, RECURRENCE, AND DYSPAREUNIA. (B)(4).

    Additional Manufacturer Narrative · 1

    DATE SENT TO FDA: 5/11/2016. ADDITIONAL INFORMATION: AGE AT TIME OF EVENT, DATE OF BIRTH.

    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. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL (B)(4) RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2011 AND MESH WAS USED. THE PATIENT EXPERIENCED MULTIPLE COMPLICATIONS, INCLUDING EROSION, FORMATION OF SCAR TISSUE, ADDITIONAL SURGERIES AND NEUROLOGIC COMPROMISE TO HER STRUCTURES AND TISSUES. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 3521147

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention