BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT OBURATOR SYSTEM

    MDR report key: 3150594 · Received June 6, 2013

    Report

    Report Number
    2210968-2013-10014
    Event Type
    Injury
    Date Received
    June 6, 2013
    Report Date
    May 14, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THE PATIENT UNDERWENT A COMPLEX URODYNAMIC AND PLACED A 54 POSTOP SLING ON (B)(6) 2011. IT WAS REPORTED THAT PATIENT UNDERWENT INTERSTIM IMPLANTATION, INCLUDING TINED LEAD S3 ON THE LEFT, PLUS THE IPG INTERSTIM PULSE GENERATOR, PLUS INTRAOPERATIVE FLUOROSCOPY ON (B)(6) 2011. A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4). 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): FOLLOWING MESH IMPLANTATION, THE PATIENT EXPERIENCED PAIN, EROSION, INFECTION, VAGINAL SCARRING, URINARY AND NEUROMUSCULAR PROBLEMS. IT WAS REPORTED THAT PATIENT UNDERWENT REVISION OF SLING WITH EXCISION OF EXPOSED VAGINAL TAPE, DEBRIDEMENT OF PERIURETHRAL TISSUES WITH FLAP CLOSURE OF DEFECT AND CYSTOSCOPY ON (B)(6) 2011. (B)(4).

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 05/31/2016. (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED DETRUSOR INSTABILITY, RECTOCELE, NOCTURIA, AND FREQUENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007, AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT A RETURN TO THE OPERATING ROOM FOR EXAMINATION UNDER ANESTHESIA, SUTURING OF THE VAGINAL WALL AND VAGINAL PACK PLACEMENT DUE TO FOR VAGINAL BLEEDING. IT WAS REPORTED THAT PATIENT UNDERWENT B/L INTERSTIM TEST STIMULATION PROCEDURE WITH INTRAOPERATIVE FLUOROSCOPY ON (B)(6) 2011, DUE TO URGENCY AND URGE INCONTINENCE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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) 2007 AND MESH WAS IMPLANTED TO TREAT STRESS URINARY INCONTINENCE. IT IS REPORTED THAT THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL TISSUES, AND SHE HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251704 GYNECARE TVT OBURATOR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. UNK 3041481

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention