BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE GYNEMESH* PS

    MDR report key: 2972679 · Received February 21, 2013

    Report

    Report Number
    2210968-2013-01450
    Event Type
    Injury
    Date Received
    February 21, 2013
    Report Date
    January 31, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTO
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT SYMPTOMATIC RECTOCELE AND THE PATIENT UNDERWENT THE CONCURRENT PROCEDURE OF PELVIC FLOOR REPAIR. THE PATIENT UNDERWENT FOLLOW-UP SURGERIES TO RECTOCELE IN 2009 AND 2010. IT WAS REPORTED THAT PATIENT UNDERWENT MESH REVISION ON AN UNKNOWN DATE FOLLOWED BY ANOTHER SURGERY ON (B)(6) 2010 FOR RESECTION OF VULVAR FOURCHETTE LESION, EXTERIORIZATION OF THE VAGINA AND CLOSURE OF THE DEFECT. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    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

    IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY ON (B)(6) 2008 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76992 GYNECARE GYNEMESH* PS MESH, SURGICAL, POLYMERIC OTO ETHICON, INC. NA ALR027

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention