BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT RETROPUBIC SYSTEM

    MDR report key: 3182109 · Received June 21, 2013

    Report

    Report Number
    2210968-2013-10724
    Event Type
    Injury
    Date Received
    June 21, 2013
    Report Date
    July 1, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K974098
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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 FOLLOWING INSERTION THE PATIENT EXPERIENCED CYSTITIS AND ATROPHIC VAGINITIS. IT WAS REPORTED THAT PATIENT UNDERWENT INSERTION OF MESH (PROLIFT) ON (B)(6) 2007 BY DR. (B)(6) DUE TO RECTOCELE. IT WAS REPORTED THAT PATIENT UNDERWENT MESH REVISION ON (B)(6) 2007, (B)(6) 2008, (B)(6) 2008 AND (B)(6) 2010 BY DR. (B)(6) AND DR. (B)(6) DUE TO ERODED AND EXTRUDED MESH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 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
    283505 GYNECARE TVT RETROPUBIC SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL FTL ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention