BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT SECUR SYSTEM

    MDR report key: 3211423 · Received July 8, 2013

    Report

    Report Number
    2210968-2013-12356
    Event Type
    Injury
    Date Received
    July 8, 2013
    Report Date
    July 20, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    PAH
    PMA / PMN Number
    K052401
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2008 AND A MESH WAS IMPLANTED, CONCURRENTLY WITH A HYSTERECTOMY DUE TO SUI/POP, CYSTOCELE, RECTOCELE, CERVICAL DYSPLASIA, METRORRHAGIA, AND PELVIC PAIN. IT WAS REPORTED THAT PATIENT UNDERWENT EXCISION OF EXPOSED MESH WITH PRIMARY CLOSURE OF THE VAGINAL CUFF ON (B)(6) 2010 DUE TO A SMALL AREA OF LEFT VAGINAL CUFF MESH EXPOSURE. THE PATIENT UNDERWENT AN EXCISION OF AN EXPOSED VAGINAL MESH, CYST AND PERITONEOPLASTY ON (B)(6) 2011 DUE TO DYSPAREUNIA AND EXPOSED VAGINAL MESH WITH INTROITAL NARROWING. THE PATIENT UNDERWENT A REMOVAL OF GRANULATED VAGINAL TISSUE ON (B)(6) 2013 DUE TO PRESENCE OF GRANULATED VAGINAL TISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    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). 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) 2008 AND MESH WERE IMPLANTED. IT WAS REPORTED THAT SHE 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
    308681 GYNECARE TVT SECUR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC PAH ETHICON INC. 2992801

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention