BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3162366 · Received June 11, 2013

    Report

    Report Number
    2210968-2013-06792
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    May 2, 2018
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K100936
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT STRESS URINARY INCONTINENCE, URETHRAL HYPERMOBILITY, AND UTERINE LEIOMYOMATA. IT WAS REPORTED THAT THE PATIENT HAD A CONCURRENT PROCEDURE OF A CYSTOSCOPY PERFORMED DURING MESH IMPLANTATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 ON (B)(6) 2013 AND MESH WAS IMPLANTED CONCURRENTLY WITH HYSTERECTOMY, DUE TO STRESS URINARY INCONTINENCE. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EXTRUSION, URINARY/BOWEL PROBLEMS, AND DYSPAREUNIA. IT WAS REPORTED THAT PATIENT UNDERWENT REVISION OF MESH ON (B)(6) 2013 AND PARTIAL REMOVAL ON 04/08/2013. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH LSH. THE PATIENT FEELS STRESS URINARY INCONTINENCE; IT HAS BEEN A PROBLEM SINCE HER LAST CHILD BORN 13 YEARS AGO. SHE REPORTS URGENCY WHEN HAVING INTERCOURSE, LAUGH, COUGH, OR SNEEZE. IT WAS REPORTED THE PATIENT HAD A REVISION ON (B)(6) 2013 DUE TO COMPLICATIONS OF GENITOURINARY IMPLANT WITH EXPOSURE OF MESH. THERE WAS APPROXIMATELY 1 CM WIDE MIDLINE DEFECT WITH EXPOSURE OF THE MESH EVIDENCED ON EXAM. IT WAS REPORTED THAT ON (B)(6) 2013 THE PATIENT UNDERWENT LAPAROSCOPIC OVARIAN CYSTECTOMY, LYSIS OF ADHESIONS, REVISION OF MESH WITH EXCISION OF EXPOSED SLING, AND CYSTOSCOPY. FINDINGS SHOWED ENLARGED LEFT OVARY 6 CM ADHERED TO THE SIGMOID COLON. THE RECTO SIGMOID IS ADHERED TO THE APEX AND POSTERIOR PORTION OF THE CERVIX. THE RIGHT OVARY ALSO HAS ADHESIONS AROUND IT BUT OF NORMAL SIZE AND SLIGHTLY MOBILE. APPROXIMATELY 2 CM OF MESH WAS EXPOSED IN THE VAGINA, WHICH WAS REMOVED. BOTH URETERS WERE FOUND TO BE EFFLUXING INDIGO CARMINE AT THE END OF THE PROCEDURE. NO MESH IN THE BLADDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2013 AND MESH WAS 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
    261842 TENSION FREE VAGINAL TAPE MESH, SURGICAL OTN ETHICON, INC. NA 3621917

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention