BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT SECUR SYSTEM

    MDR report key: 3842824 · Received June 2, 2014

    Report

    Report Number
    2210968-2014-06906
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    February 2, 2012
    Report Date
    May 22, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    PAH
    PMA / PMN Number
    K052401
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 11/20/2015. 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. THIS MEDWATCH REPORT IS IN RESPONSE TO RECEIPT OF MAUDE EVENT REPORT MW5035595.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE TO TREAT STRESS URINARY INCONTINENCE ON (B)(6) 2007 AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED PELVIC PAIN AND DYSPAREUNIA WITH EROSION OF THE MESH THROUGH THE VAGINAL WALL THAT REQUIRED REMOVAL ON (B)(6) 2012. IN 2013, THE PATIENT DEVELOPED AN AREA ON THE OUTER LABIA THAT WOULD FILL AND SPONTANEOUSLY DRAIN. THE AREA WAS TREATED WITH CLOTRIMAZOLE-BETAMETHASONE 1%-0.05% CREAM TWICE DAILY FOR 2 WEEKS WITHOUT RESOLUTION. THE PATIENT ALSO HAD A URINARY TRACT INFECTION THAT WAS TREATED WITH CIPRO. THE PATIENT RETURNED TO THE CLINIC IN 2013 WITH THE SAME SYMPTOMS. SHE UNDERWENT A TRANSVAGINAL ULTRASOUND FOR EVALUATION AND DIAGNOSIS OF PERINEAL FISTULA FORMATION. THE PATIENT IS TO UNDERGO EXPLORATION OF FISTULA AND POSSIBLE REMOVAL OF ADDITIONAL MESH. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320805 GYNECARE TVT SECUR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC PAH ETHICON INC. 3018610

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention