BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT OBURATOR SYSTEM

    MDR report key: 3240873 · Received July 22, 2013

    Report

    Report Number
    2210968-2013-13989
    Event Type
    Injury
    Date Received
    July 22, 2013
    Report Date
    July 27, 2017
    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

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED SEVERE PAIN IN RIGHT SIDE, INCONTINENCE, DYSPAREUNIA, OCCASIONAL BLOOD IN URINE, PAINFUL URINATION, DRIBBLING OF URINE AFTER VOIDING, AND FREQUENT UTIS. IT WAS REPORTED THAT PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2008.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE MESH REMOVAL ON 11/11/2008 THE PATIENT UNDERWENT WAS A PARTIAL ONE.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2008 AND A MESH WAS IMPLANTED DUE TO SUI.

    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

    DATE SENT TO THE FDA: 07/28/2017 ADDITIONAL INFORMATION:

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2008 AND MESH WAS IMPLANTED INTO THE PATIENT. IT IS REPORTED THAT THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES, 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
    340897 GYNECARE TVT OBURATOR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. UNK 3067995

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention