BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3123688 · Received May 22, 2013

    Report

    Report Number
    2210968-2013-05687
    Event Type
    Injury
    Date Received
    May 22, 2013
    Report Date
    May 2, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K012628
    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.

    Additional Manufacturer Narrative · 1

    THE PATIENT UNDERWENT MESH IMPLANTATION CONCURRENTLY WITH ENTEROCELE REPAIR, UTEROSACRAL COLPOPEXY, POSTERIOR COLPORRHAPHY, CYSTOURETHROSCOPY, AND EXCISION OF RIGHT INGUINAL SKIN TAG ON (B)(6) 2011; DUE TO STRESS URINARY INCONTINENCE, VAGINAL/UTERINE PROLAPSED, RECTOCELE, CYSTOCELE, ENTEROCELE, URETHRAL HYPERMOBILITY, AND INTERSTITIAL CYSTITIS. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED CHRONIC PELVIC AND VAGINAL AREA PAIN, CONTINUED URINARY INCONTINENCE, RETENTION AND LEAKAGE, VAGINAL SCARRING, URINARY, VAGINAL AND YEAST INFECTIONS (X7), PAIN IN URETHRA WHILE URINATING AND ABNORMAL BOWEL MOVEMENTS, CHRONIC WEAKNESS, FEVER, BLOOD IN MY URINE, AND OVERALL DECREASE IN HEALTH, PHYSICAL PAIN AND DISCOMFORT AS WELL AS SEVERE DEPRESSION AND ANXIETY. (B)(4). 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) 2011 AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF INTERNAL BODILY TISSUE AND OTHER INJURIES, AND HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226092 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 3514255

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention