BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT OBURATOR SYSTEM

    MDR report key: 3222717 · Received July 12, 2013

    Report

    Report Number
    2210968-2013-12967
    Event Type
    Injury
    Date Received
    July 12, 2013
    Report Date
    September 5, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    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). 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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN CYSTOSCOPY AND URODYNAMICS ON (B)(6) 2012, (B)(6) 2013 AND ON (B)(6) 2012 PATIENT UNDERWENT CYSTOURETHROSCOPY. IT WAS REPORTED THAT PATIENT UNDERWENT EXTENSIVE TRANSVAGINAL AND ABDOMINAL URETHROLYSIS WITH REMOVAL OF THE MESH ON (B)(6) 2012 DUE TO VAGINAL WALL EROSION POST TENSION FREE VAGINAL TAPE, MESH COMPLICATIONS, PELVIC PAIN DUE TO MESH AND DYSPAREUNIA. IT WAS REPORTED THAT PATIENT UNDERWENT EXTENSIVE TRANSVAGINAL URETHROLYSIS, REPAIR OF SUPRAPUBIC INCISIONAL HERNIA AND CREATION OF AUTOLOGOUS FASCIAL SLING WITH DONOR SITE OF THE LOWER ABDOMEN ON (B)(6) 2013. IT WAS REPORTED THAT PATIENT UNDERWENT AN EXCISION ON UNDISCLOSED DATE DUE TO SEVERE URINARY INCONTINENCE AND POST REMOVAL OF MESH DUE TO COMPLICATIONS. IT WAS REPORTED THAT PATIENT UNDERWENT ABDOMINAL EXPLORATION TO REPAIR OF LARGE LEFT BLADDER HERNIA (INCISIONAL), CYSTOCELE REPAIR, CENTRAL DEFECT, ENTEROCELE REPAIR AND RECTOCELE REPAIR USING A HIGH LEVATOR MYORRHAPHY TECHNIQUE ON (B)(6) 2014. PATIENT HAD ANOTHER EXCISION ON AN UNDISCLOSED DATE DUE TO VAGINAL PROLAPSE, ENTEROCELE, RECTOCELE, LARGE INCISIONAL HERNIA AND PARTIAL SLING.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ALONG WITH CONCURRENT TVH, ANTERIOR COLPORRHAPHY WITH XENAFORM GRAFT, VAGINAL VAULT SUSPENSION AND POSTERIOR REPAIR DUE TO LARGE CYSTOCELE (THIRD DEGREE) AND MILD SUI. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, INFECTION, URINARY/BOWEL PROBLEMS, FISTULAE, BLEEDING, DYSPAREUNIA AND VAGINAL SCARRING. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    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) 2008 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
    323342 GYNECARE TVT OBURATOR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. UNK 3109822

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention