BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT OBURATOR SYSTEM

    MDR report key: 3221425 · Received July 11, 2013

    Report

    Report Number
    2210968-2013-12854
    Event Type
    Injury
    Date Received
    July 11, 2013
    Report Date
    July 8, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT HAD A GYNECOLOGICAL PROCEDURE IN ORDER TO TREAT CYSTOCELE, RECTOCELE, ENTEROCELE, VAGINAL VAULT PROLAPSE , BLADDER FOREIGN BODY AND STONE AND STRESS URINARY INCONTINENCE AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT HAD THE FOLLOWING CONCURRENT PROCEDURES: (B)(6) 2008- VAGINAL SLING, URETHROPEXY, CYSTOSCOPY; (B)(6) 2013- ANTERIOR COLPORRHAPHY, POSTERIOR COLPORRHAPHY WITH MESH AUGMENTATION, EXCISION OF BLADDER FOREIGN BODY AND STONE VIA CYSTOTOMY, REVISION AND EXCISION OF SUBURETHRAL SLING, LYSIS OF PELVIC ADHESIONS, BILATERAL SACROSPINOUS COLPOPEXY WITH POSTERIOR ELEVATE MESH SYSTEM, SUBURETHRAL SLING WITH TENSION-FREE VAGINAL TAPE, CYSTOURETHROSCOPY PERFORMED DURING MESH IMPLANTATION. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 20/08 AND MESH WAS IMPLANTED. IT WAS ALSO REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2013 AND MESH AND ELEVATE 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
    319943 GYNECARE TVT OBURATOR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. UNK 3646874

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention