BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2982528 · Received February 28, 2013

    Report

    Report Number
    2210968-2013-01876
    Event Type
    Injury
    Date Received
    February 28, 2013
    Report Date
    September 5, 2024
    Manufacturer
    ETHICON INC
    Product Code
    OTN
    PMA / PMN Number
    K974098
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    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

    THIS REPORT IS FOLLOW UP 02 BEING RESUBMITTED AS FOLLOW UP 02 AS REQUESTED BY ESG DUE TO A DB CONNECTION ISSUE THAT OCCURRED WHEN THE ORIGINAL SUBMISSION WAS MADE ON (B)(6) 2014. (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH LYSIS ADHESIONS, RIGHT SALPINGO-OOPHORECTOMY AND CYSTOSCOPY DUE TO CHRONIC PELVIC PAIN, STRESS URINARY INCONTINENCE AND CYSTOCELE. FOLLOWING INSERTION, THE PATIENT EXPERIENCED PAIN, EROSION, INFECTION, URINARY/BOWEL PROBLEMS , RECURRENCE, BLEEDING AND DYSPAREUNIA. THE PATIENT UNDERWENT MESH REVISION ON (B)(6) 2002. THE PATIENT UNDERWENT SURGERY FOR LYSIS OF EXTENSIVE ADHESIONS OF HER COLON AND SMALL INTESTINE ON (B)(6) 2003. THE PATIENT DEVELOPED A POSTOPERATIVE ILEUS ON (B)(6) 2003. (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED DUE TO PROLAPSED BLADDER. THE PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION, INFECTION, URINARY/BOWEL PROBLEMS, BLEEDING, DYSPAREUNIA, NEUROMUSCULAR PROBLEMS AND VAGINAL SCARRING. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REVISION/REMOVAL ON (B)(6) 2013 FOR EXCISION OF MESH DUE TO VAGINAL MESH EROSION, PELVIC PAIN AND ABDOMINAL PAIN. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REVISION/REMOVAL ON (B)(6) 2013 FOR EXCISION OF MESH LYSIS OF ADHESIONS DUE TO VAGINAL MESH EROSION, PELVIC PAIN, ABDOMINAL PAIN. IT WAS REPORTED THAT THE PATIENT UNDERWENT EXCISION OF THE VAGINAL MESH, URETHROLYSIS, AND CYSTOURETHROSCOPY ON (B)(6) 2013. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) /2002 AND A SLING WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. 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
    87084 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON INC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female Required Intervention NI.