BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE GYNEMESH* PS

    MDR report key: 2955636 · Received February 11, 2013

    Report

    Report Number
    2210968-2013-00966
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    January 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
    MN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): IT WAS REPORTED THAT THE PATIENT UNDERWENT EXCISION OF PREVIOUSLY IMPLANTED MESH CONCURRENTLY WITH IMPLANTATION OF A SLING ON (B)(6) 2011. IT WAS REPORTED THAT NO INFORMATION WAS PROVIDED REGARDING ANY ISSUES POST SURGERY ON (B)(6) 2011.

    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. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. THIS IS ONE OF THREE MEDWATCHES BEING SUBMITTED. SEE ALSO MEDWATCH 2210968-2012-04793 AND MEDWATCH 2210968-2013-00967. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY TO EXCISE PREVIOUSLY IMPLANTED PAINFUL, ERODED VAGINAL MESH CONCURRENTLY WITH ANTERIOR COLPORRHAPHY WITH DERMAL ALLOGRAFT PLACEMENT, ABDOMINAL ENTEROCELE REPAIR AND SACROCERVICOPEXY ON (B)(6) 2011 AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED MULTIPLE COMPLICATIONS, INCLUDING EROSION, FORMATION OF SCAR TISSUE, ADDITIONAL SURGERIES AND NEUROLOGIC COMPROMISE TO HER STRUCTURES AND TISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59926 GYNECARE GYNEMESH* PS MESH, SURGICAL, POLYMERIC OTO ETHICON, INC. NA DJE967

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention