BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2914174 · Received January 14, 2013

    Report

    Report Number
    2210968-2013-00264
    Event Type
    Injury
    Date Received
    January 14, 2013
    Report Date
    July 8, 2019
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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

    (B)(4): THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE TO TREAT STRESS URINARY INCONTINENCE AND A SLING WAS IMPLANTED. IT WAS REPORTED POST IMPLANTATION THE PATIENT EXPERIENCED RECURRENCE OF EROSION, INFECTION, BLEEDING, VAGINAL SCARRING AND DYSPAREUNIA. THE PATIENT HAD A PARTIAL SLING REVISION AND CYSTOCELE REPAIR ON (B)(6) 2011 DUE TO MESH EROSION, PELVIC ORGAN PROLAPSED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH CYSTOSCOPY. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2010 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT EXTENSIVE TRANSVAGINAL URETHROLYSIS, ABDOMINAL VAGINAL EXPLORATION, AND REMOVAL OF RETROPUBIC MESH ON (B)(6) 2013 DUE TO SEVERE PELVIC PAIN, DYSPAREUNIA, POST VAGINAL MESH EROSION, SYSTEMIC EFFECT WITH MYALGIA, URINARY INCONTINENCE, AND PELVIC PAIN. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY RETENTION, VAGINAL DISCHARGE AND ADHESIONS.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URGENCY.

    Additional Manufacturer Narrative · 1

    DATE SENT TO FDA: 7/9/2019. (B)(4). ADDITIONAL NARRATIVE: IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED SPASM, DISCOMFORT AND HEMATURIA. IT WAS REPORTED THAT PATIENT UNDERWENT REVISION AND REMOVAL OF MESH ON (B)(6) 2011 AND (B)(6) 2013. (B)(4) REPRESENTS THE ADVERSE EVENT WHICH OCCURRED ON (B)(6) 2011. (B)(4) REPRESENTS THE ADVERSE EVENT WHICH OCCURRED ON (B)(6) /2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT GYNECOLOGICAL PROCEDURE ON (B)(6) 2010 AND MESH WAS USED. THE PATIENT EXPERIENCED MULTIPLE COMPLICATIONS, INCLUDING EROSION, FORMATION OF SCAR TISSUE, ADDITIONAL SURGERIES AND NEUROLOGIC COMPROMISE TO HER STRUCTURES AND TISSUES. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21584 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 3379982

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention