BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE GYNEMESH* PS

    MDR report key: 3102207 · Received May 9, 2013

    Report

    Report Number
    2210968-2013-05334
    Event Type
    Injury
    Date Received
    May 9, 2013
    Report Date
    April 16, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTO
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT PROLAPSE. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION, INFECTIONS, REVISIONS, URINARY PROBLEMS, RECURRENCE, BLEEDING, DYSPAREUNIA, NEUROMUSCULAR PROBLEMS AND VAGINAL SCARRING. IT WAS REPORTED THAT PATIENT UNDERWENT 3 MESH REVISIONS IN 2012 DUE TO MESH EROSION. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REVISION ON (B)(6) 2005 DUE TO EROSION.

    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

    IT WAS BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2004 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXCISION OF ERODED MESH ON (B)(6) 2012. THE PATIENT UNDERWENT AN ABDOMINAL FASCIAL SLING HARVEST AND TRANSVAGINAL MID-URETHRAL FASCIAL SLING PLACEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2004 AND MESH AND IVS TUNNELLER WERE IMPLANTED. THE PATIENT EXPERIENCED MULTIPLE COMPLICATIONS, INCLUDING EROSION, FORMATION OF SCAR TISSUE, ADDITIONAL SURGERIES AND NEUROLOGIC COMPROMISE TO HER STRUCTURES AND TISSUES. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203590 GYNECARE GYNEMESH* PS MESH, SURGICAL, POLYMERIC OTO ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention IVS TUNNELLER