BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE GYNEMESH PS

    MDR report key: 1973880 · Received January 20, 2011

    Report

    Report Number
    2210968-2011-00059
    Event Type
    Injury
    Date Received
    January 20, 2011
    Report Date
    January 5, 2011
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAW AT THIS TIME. SHOULD ADDITIONAL INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 10/2212015. 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 PT UNDERWENT A SURGICAL PROCEDURE TO TREAT STRESS URINARY INCONTINENCE AND PELVIC ORGAN PROLAPSE ON (B)(6) 2005 AND MESH WAS IMPLANTED. ON (B)(6) 2005, THE PT WAS IMPLANTED WITH AMS MONARC SUBFASCIAL HAMMOCK. THE PT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE, AND OTHER INJURIES FOLLOWING THE PROCEDURE. THE PT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFO WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2005 AND MESH WAS IMPLANTED CONCURRENTLY WITH CALDERA MEDICAL T-SLING DUE TO PELVIC RELAXATION AND SUI. IT WAS REPORTED THAT THE PATIENT UNDERWENT EXCISION OF MESH AND REPAIR OF CYSTOCELE AND ANTERIOR WALL DEFECT ON (B)(6) 2005 DUE TO PREVIOUS CYSTOCELE REPAIR WITH SOFT MESH AND MESH EROSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYNECARE GYNEMESH PS MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA TKE095

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention AMS MONARC SUBFASCIAL HAMMOCK