BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT OBTURATOR SYSTEM

    MDR report key: 3221742 · Received July 11, 2013

    Report

    Report Number
    2210968-2013-12887
    Event Type
    Injury
    Date Received
    July 11, 2013
    Report Date
    March 16, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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). 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). IT WAS REPORTED THAT MESH WAS IMPLANTED DUE TO STRESS URINARY INCONTINENCE, INCOMPLETE UTERINE PROLAPSE, GRADE III, HYPERMOBILE URETHRAL JUNCTION, SYMPTOMATIC RECTOCELE AND CYSTOCELE AND RECTAL LESION ALONG WITH CONCURRENT LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY, LYSIS OF ADHESIONS LAPAROSCOPICALLY, CYSTOCELE REPAIR, RECTOCELE REPAIR, CYSTOURETHROSCOPY, LIGAMENT SUSPENSION AND RECTAL LESION EXCISION. IT WAS ALSO REPORTED THAT THE PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2013 DUE TO MESH EXPOSURE, VAGINAL DISCHARGE, VAGINAL BLEEDING, PAIN AND DISCOMFORT. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2006 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
    320638 GYNECARE TVT OBTURATOR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. 2919646

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention