BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT RETROPUBIC SYSTEM

    MDR report key: 3162081 · Received June 11, 2013

    Report

    Report Number
    2210968-2013-10071
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    June 16, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    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

    IT WAS REPORTED THAT PATIENT UNDERWENT MESH REMOVAL AND CYSTOSCOPY (B)(6) 2010 DUE TO PERFORATION OF THE URINARY BLADDER. (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT REMOVAL OF MESH TAPE AND CYSTOSCOPY ON (B)(6) 2011 DUE TO TOT MESH IN BLADDER WITH SECONDARY UTIS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2004 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT LEFT OOPHORECTOMY ON (B)(6) 2009. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2004 AND A MESH WAS IMPLANTED DUE TO SUI. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED EXTRUSION, INFECTION, URINARY PROBLEMS, ORGAN PERFORATION, AND VAGINAL SCARRING. IT WAS ALSO REPORTED THAT THE PATIENT UNDERWENT PARTIAL REMOVAL OF VAGINAL MESH ON (B)(6) 2004 DUE TO MESH FAILURE ALONG WITH MESH EROSION, EXCISION OF THE INTRAVESICAL PORTION OF THE SLING ON (B)(6) 2008 DUE TO PERFORATION OF THE BLADDER WITH SLING AND REMOVAL OF MESH ON (B)(6) 2010 DUE TO MESH FAILURE ALONG WITH EROSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2004 AND MESH WAS IMPLANTED INTO THE PATIENT. 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
    263385 GYNECARE TVT RETROPUBIC SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. UNK 1128993

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention