BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT RETROPUBIC SYSTEM

    MDR report key: 3211466 · Received July 8, 2013

    Report

    Report Number
    2210968-2013-12364
    Event Type
    Injury
    Date Received
    July 8, 2013
    Report Date
    November 25, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K974098
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND A MESH WAS IMPLANTED.

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 12/1/2016.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT ON (B)(6) 2012 THE PATIENT UNDERWENT TRANSVAGINAL REVISION OF MESH DUE TO VAGINAL BURNING AND VAGINAL BULGE. ON (B)(6) 2013 AND (B)(6) 2013 A SURGICAL PROCEDURE WAS PERFORMED TO CORRECT HER POP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 TO TREAT POP AND SUI, AND A MESH AND SLING WERE IMPLANTED INTO THE PATIENT. IT IS ALSO REPORTED THAT THE PATIENT EXPERIENCED PAIN WITH SEXUAL INTERCOURSE, VAGINAL SCARRING/SHRINKAGE, SPOTTING, EROSION OF INTERNAL TISSUES, AND 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
    312030 GYNECARE TVT RETROPUBIC SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC FTL ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention