BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3050883 · Received April 10, 2013

    Report

    Report Number
    2210968-2013-03710
    Event Type
    Injury
    Date Received
    April 10, 2013
    Report Date
    March 22, 2013
    Manufacturer
    ETHICON, INC
    Product Code
    OTN
    PMA / PMN Number
    K100936
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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).

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: THE PATIENT UNDERWENT MESH IMPLANTATION CONCURRENTLY WITH LAPAROSCOPICALLY ASSISTED VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY, EXTENSIVE PERITONECTOMY, AND EXTENSIVE ADHESIOLYSIS. THE REASON FOR THESE PROCEDURES WERE: MENORRHAGIA, UTERINE FIBROIDS, DYSMENORRHEA, STRESS URINARY INCONTINENCE, SYMPTOMATIC VAGINAL RELAXATION , CYSTOCELE, RECTOCELE AND ENTEROCELE, PELVIC MASS CONSISTENT WITH LEIOMYOMATA, MENOMETRORRHAGIA, DYSMENORRHEA, DYSPAREUNIA, CHRONIC PMS, SCLERODERMA, EVIDENCE OF PELVIC INFLAMMATORY DISEASE, AND CURTIS FITZ- HUGH SYNDROME. IT WAS REPORTED THAT PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2011 BECAUSE IT WAS CONCLUDED THAT THE MESH WAS NOT WORKING PROPERLY. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2011 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
    149997 TENSION FREE VAGINAL TAPE MESH, SURGICAL OTN ETHICON, INC NA 3492243

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention