BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3053256 · Received April 11, 2013

    Report

    Report Number
    2210968-2013-03723
    Event Type
    Injury
    Date Received
    April 11, 2013
    Report Date
    March 22, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2013-03726. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT STRESS URINARY INCONTINENCE, VAGINAL VAULT PROLAPSE, UTERINE PROLAPSE, RECTOCELE, WEAK RECTOVAGINAL TISSUE AND INTRINSIC SPHINCTER INSUFFICIENCY. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PRESSURE IN VAGINAL AREA, CAN HARDLY SIT OR STAND WHEN HAVING PRESSURE, RECURRENT URINARY TRACT INFECTIONS, VAGINAL BLEEDING, WORSENING STRESS INCONTINENCE, CONSTANT LEAKAGE, SEVERE MESH EROSION, VAGINAL ATROPHY, YEAST INFECTIONS, UNABLE TO CONTROL URINE, VAGINAL EROSION, PERSISTENT PELVIC PAIN, NOCTURIA, INCREASING FREQUENCY, PELVIC PAIN, PRESSURE IN VAGINAL AREA. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2008 AND MESH WAS IMPLANTED CONCURRENTLY WITH CYSTOURETHROSCOPY DUE TO SUI AND INTRINSIC SPHINCTER INSUFFICIENCY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2008 AND (B)(6) 2008 AND MESH AND DIMA NEEDLELESS WERE IMPLANTED. THE DATES OF SPECIFIC PRODUCT WERE NOT CLARIFIED. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154626 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 3135652

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention