BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2914016 · Received January 14, 2013

    Report

    Report Number
    2210968-2013-00273
    Event Type
    Injury
    Date Received
    January 14, 2013
    Report Date
    December 19, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K974098
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2000 DUE TO CHRONIC PELVIC PAIN, ABNORMAL UTERINE BLEEDING, OVARIAN CYSTS AND CHRONIC LEFT ADREXAL PAIN, STRESS URINARY INCONTINENCE, PELVIC RELAXATION WITH THIRD DEGREE CYSTOCELE AND THIRD DEGREE RECTOCELE. THE PATIENT UNDERWENT THE CONCURRENT PROCEDURES OF A VAGINAL HYSTERECTOMY, LEFT SALPINGO-OOPHORECTOMY, ANTERIOR, POSTERIOR AND ENTEROCELE REPAIR DURING MESH IMPLANTATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT UNDERWENT MESH IMPLANTATION CONCURRENTLY WITH HYSTERECTOMY DUE TO PELVIC RELAXATION SYNDROME, CYSTOCLE, RECTOCELE, LEFT ADENEXAL PAIN, AND STRESS URINARY INCONTINENCE. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, INFECTION, URINARY/BOWEL PROBLEMS, RECURRENCE AND DYSPAREUNIA. IT WAS REPORTED THAT PATIENT UNDERWENT MESH REVISION ON (B)(6) 2006 DUE TO BLADDER PROLAPSE. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2000 AND MESH WAS USED. 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
    20833 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 813960

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention