BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE GYNEMESH* PS

    MDR report key: 3142794 · Received June 3, 2013

    Report

    Report Number
    2210968-2013-06412
    Event Type
    Injury
    Date Received
    June 3, 2013
    Report Date
    May 14, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTO
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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 REPORTED THAT THE PATIENT UNDERWENT MESH EXCISION AND WOUND REVISION WITH SECONDARY CLOSURE OF VAGINAL TISSUE, APPROXIMATELY 4 CM ON (B)(6) 2005 BY DR. (B)(6) DUE TO VAGINAL TISSUE BREAKDOWN WITH MESH EXPOSURE AND VAGINAL MESH EROSION. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REVISION, REMOVAL OF MESH AND OVER SEWING OF DEFECT ON (B)(6) 2009 BY DR. (B)(6) DUE TO VAGINAL MESH EXPOSURE WITH GRANULATION TISSUE AND BLEEDING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE TO TREAT PELVIC ORGAN PROLAPSE ON (B)(6) 2005 AND MESH WAS PLACED INTO THE PATIENT¿S BODY. IT WAS REPORTED THAT 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.

    Description of Event or Problem · 1

    DETAILS: IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH EXCISION AND WOUND REVISION WITH SECONDARY CLOSURE OF VAGINAL TISSUE, APPROXIMATELY 4 CM ON (B)(6) 2005 BY DR. (B)(6) DUE TO VAGINAL TISSUE BREAKDOWN WITH MESH EXPOSURE AND VAGINAL MESH EROSION. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REVISION, REMOVAL OF MESH AND OVER SEWING OF DEFECT ON (B)(6) 2009 BY DR. (B)(6) DUE TO VAGINAL MESH EXPOSURE WITH GRANULATION TISSUE AND BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245193 GYNECARE GYNEMESH* PS MESH, SURGICAL, POLYMERIC OTO ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention