BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT OBURATOR SYSTEM

    MDR report key: 3222275 · Received July 12, 2013

    Report

    Report Number
    2210968-2013-12899
    Event Type
    Injury
    Date Received
    July 12, 2013
    Report Date
    July 18, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ALONG WITH THE CONCURRENT PROCEDURES ANTERIOR & POSTERIOR REPAIR, BILATERAL SACROSPINOUS LIGAMENT FIXATION WITH IVS TUNNELER DEVICE DUE TO SYMPTOMATIC APICAL VAGINAL VAULT PROLAPSE, CYSTOCELE, RECTOCELE, ENTEROCELE AND STRESS URINARY INCONTINENCE. IT WAS REPORTED THAT THE PATIENT HAD AN IVS TUNNELER DEVICE IMPLANTED ON (B)(6) 2005 ALONG WITH MESHES. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION/REMOVAL OF MESHES ON (B)(6) 2006. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION/REMOVAL OF IVS MESH ON (B)(6) 2007 WITH RECONSTRUCTION OF VAGINAL VAULT. IT WAS REPORTED THAT THE PATIENT UNDERWENT EXCISION OF VAGINAL MESH ON (B)(6) 2010, ALONG WITH ENTEROCELE REPAIR.

    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

    .

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2005, AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT A CYSTOSCOPY AND EUA ON (B)(6) 2009, DUE TO PELVIC PAIN, MESH PROTRUSION AT THE APEX. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2005 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
    321475 GYNECARE TVT OBURATOR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IVS TUNNELER