BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3132743 · Received May 29, 2013

    Report

    Report Number
    2210968-2013-05995
    Event Type
    Injury
    Date Received
    May 29, 2013
    Report Date
    May 7, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    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): 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). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED DUE TO SYMPTOMATIC PELVIC OPEN PROLAPSE, CYSTOCELE, CENTRAL DEFECT, AND STRESS URINARY INCONTINENCE. ON (B)(6) 2011, THE PATIENT WAS ADMITTED FOR AN ACUTE KIDNEY INJURY SECONDARY TO OUTLET OBSTRUCTION AND URINARY TRACT INFECTION. THE PATIENT UNDERWENT MESH REVISION/REMOVAL ON (B)(6) 2011 DUE TO URINARY RETENTION, PUCKERING IN THE POSTEROLATERAL VAGINAL VAULT AND PELVIC PAIN. THE PATIENT EXPERIENCED URINARY RETENTION, CATHETERIZATION AND URINARY TRACT INFECTIONS, PAIN, EROSION, EXTRUSION, INFECTIONS, URINARY PROBLEMS, FISTULAE, RECURRENCE, BLEEDING AND VAGINAL SCARRING. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2011 AND MESH AND ELEVATE WERE 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
    236915 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 3436340

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention