BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3061817 · Received April 16, 2013

    Report

    Report Number
    2210968-2013-03970
    Event Type
    Injury
    Date Received
    April 16, 2013
    Report Date
    March 28, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    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.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED CHRONIC DYSURIA, URINARY INCONTINENCE, DISCOMFORT, URGENCY, URINARY FREQUENCY, LEAKING, VAGINAL DISCHARGE, AND MILD ITCHING. IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH TOTAL VAGINAL HYSTERECTOMY, TRANSVAGINAL REPAIR OF ENTEROCELE WITH MCCALL¿S CULDOPLASTY, ANTERIOR AND POSTERIOR COLPORRHAPHY, AND CYSTOURETHROSCOPY. 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 AN UNKNOWN DATE AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES, AND SHE HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED CHRONIC DYSURIA, URINARY INCONTINENCE, DISCOMFORT, URGENCY, URINARY FREQUENCY, LEAKING, VAGINAL DISCHARGE, AND MILD ITCHING. IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH TOTAL VAGINAL HYSTERECTOMY, TRANSVAGINAL REPAIR OF ENTEROCELE WITH MCCALL¿S CULDOPLASTY, ANTERIOR AND POSTERIOR COLPORRHAPHY, AND CYSTOURETHROSCOPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161896 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. N/A 3389031

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention