BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT RETROPUBIC SYSTEM

    MDR report key: 3211360 · Received July 8, 2013

    Report

    Report Number
    2210968-2013-12474
    Event Type
    Injury
    Date Received
    July 8, 2013
    Report Date
    July 25, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED BY AN ATTORNEY THAT MESH WAS IMPLANTED TO TREAT STRESS URINARY INCONTINENCE. IT WAS ALSO REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION, INFECTION, URINARY PROBLEMS, BLEEDING, RECURRENCE, DYSPAREUNIA AND VAGINAL SCARRING. IT WAS FURTHER REPORTED THAT PATIENT EXPERIENCED DYSPAREUNIA AND UNDERWENT REMOVAL OF VERY SMALL SEGMENT OF SLING MATERIAL ON (B)(6) 2005. ADDITIONALLY, THE PATIENT UNDERWENT SCISSOR DISSECTION AND REMOVAL OF A SMALL AMOUNT OF MESH ON (B)(6) 2005. IT WAS REPORTED, THE PATIENT EXPERIENCED SLING EROSION AND DYSPAREUNIA AND UNDERWENT REVISION OF SUBURETHRAL SLING ON (B)(6) 2006. THE PATIENT UNDERWENT VAGINAL EXPLORATION WITH BIOPSY OF VAGINAL WALL, SLING REMOVAL AND CYSTOSCOPY ON (B)(6) 2012 DUE TO DYSPAREUNIA AND SLING REMNANT. (B)(4).

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2005 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT SHE 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
    309360 GYNECARE TVT RETROPUBIC SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. UNK 1174390

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention