BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT OBURATOR SYSTEM

    MDR report key: 3880793 · Received June 18, 2014

    Report

    Report Number
    2210968-2014-07802
    Event Type
    Injury
    Date Received
    June 18, 2014
    Report Date
    May 30, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INDICATION FOR PROCEDURE WAS MODERATE TO SEVERE STRESS URINARY IN CONTINENCE. THE SLING PROCEDURE WAS ON (B)(6) 2011. CONCOMITANTLY, THE PATIENT UNDERWENT A STANDARD ANTERIOR REPAIR. THE URINARY INCONTINENCE IMPROVED AFTER THE PROCEDURE AND THE PATIENT WAS ASYMPTOMATIC. THE MESH EXPOSURE WAS MIDLINE AT THE SUTURE LINE. THE PATIENT UNDERWENT A PROCEDURE ON (B)(6) 2012 WHERE 0.5CM OF EXPOSED MESH REMOVED, EDGES OF VAGINAL WALL REFRESHED AND SUTURED BACK UP.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN OBTURATOR SLING PROCEDURE ON AN UNKNOWN DATE. THE PATIENT EXPERIENCED A SMALL, ASYMPTOMATIC EXPOSURE OF MESH. THE PATIENT UNDERWENT A REVISION PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357693 GYNECARE TVT OBURATOR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL OTN ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention