BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2781247 · Received October 10, 2012

    Report

    Report Number
    2210968-2012-06412
    Event Type
    Injury
    Date Received
    October 10, 2012
    Report Date
    September 27, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): IT WAS REPORTED ON (B)(6) 2010 THE MESH WAS EXCISED IN ITS ENTIRETY . THERE WAS NO ADDITIONAL INFORMATION PROVIDED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    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). 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

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2009 AND MESH WAS IMPLANTED DUE TO RECURRENT SUI.

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2015-05409. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION, INFECTION, URINARY PROBLEMS, FISTULAE, RECURRENCE, DYSPAREUNIA, VAGINAL SCARRING AND OTHER. IT WAS REPORTED THAT THE PATIENT UNDERWENT URETHRA-VAGINAL FISTULECTOMY AND FASCIAL PUBOVAGINAL SLING IMPLANT, CYSTOSCOPY-DEFECT IN MID-URETHRA ON (B)(6) 2011 DUE TO URETHROVAGINAL FISTULA, RECURRENT SUI. IT WAS REPORTED THAT THE PATIENT UNDERWENT ABDOMINAL WOUND EXPLORATION AND DRAINAGE OF ABSCESS ON (B)(6) 2011 DUE TO SUPRAFASCIAL WOUND ABSCESS: COMPLICATED URETHRAL FISTULA S/P REPAIR AND ONGOING LEAKAGE. IT WAS REPORTED THAT THE PATIENT UNDERWENT PELVIC EXAM UNDER GA- CYSTOSCOPY, CYSTOURETHROSCOPY ON (B)(6) 2011 DUE TO RECURRENT UI DUE TO MULTIPLE REVISIONS-SHE NOW HAS HOLE IN URETHRA. (B)(4).

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 01/16/2017. (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED DRIBBLING OF URINE, URGENCY, VAGINAL DISCHARGE, URINARY FREQUENCY, AND DYSURIA.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED VAGINITIS AND URINARY TRACT INFECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2009 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CONCURRENTLY UNDERWENT VAGINAL HYSTERECTOMY AND CYSTOSCOPY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED DRIBBLING OF URINE, URGENCY, VAGINAL DISCHARGE, URINARY FREQUENCY, AND DYSURIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 3215963

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention