BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT RETROPUBIC SYSTEM

    MDR report key: 3931283 · Received July 14, 2014

    Report

    Report Number
    2210968-2014-09051
    Event Type
    Injury
    Date Received
    July 14, 2014
    Report Date
    June 24, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT SLING PROCEDURE ON (B)(6) 2003 AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED A SMALL BLADDER PERFORATION WITH TROCARS ON THE RIGHT SIDE AND THE BLADDER PERFORATION WAS FOUND BEFORE PULLING MESH THROUGH. DURING FOLLOW-UP IN (B)(6) 2004, PATIENT WAS HAPPY WITH SLIGHTLY SLOWED URINARY STREAM AND DURING FOLLOW-UP IN (B)(6) 2004 PATIENT WAS HAPPY WITH NO SYMPTOMS. ON (B)(6) 2014, THE PATIENT UNDERWENT CYSTOURETHROSCOPY, EXPLORATION OF EXPOSED MESH, EXCISION OF GRANULATION TISSUE AND VAGINOPLASTY WITH NO EXCISION OF MESH DUE TO CONTAINMENT. THE PATIENT REMAINS CONTINENT AND WILL BE FOLLOWED UP IN THREE MONTHS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SLING PROCEDURE ON AN UNKNOWN DATE. THE PATIENT EXPERIENCED A MESH EXPOSURE RESULTING IN A SMALL BLADDER PERFORATION WHICH WAS MANAGED WITH AN INDWELLING CATHETER FOR 36 HOURS. THE PATIENT WAS STILL CONTINENT. THE PATIENT PRESENTED WITH POSTMENOPAUSAL VAGINAL BLEEDING ON (B)(6) 2014. UPON EXAMINATION, EXPOSED MESH WAS NOTED ABOVE THE RIGHT VAGINAL SULCUS. THE PATIENT WAS PRESCRIBED TOPICAL ESTROGEN. THERE IS A PLAN FOR CYSTOURETHROSCOPY, EXPLORATION OF THE EXPOSED MESH, VAGINOPLASTY OR MESH EXCISION AND RESUTURING OF VAGINAL DEPENDING ON FINDINGS UNDER ANAESTHESIA. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410906 GYNECARE TVT RETROPUBIC SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention