BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE GYNEMESH* PS

    MDR report key: 3103505 · Received May 9, 2013

    Report

    Report Number
    2210968-2013-05079
    Event Type
    Injury
    Date Received
    May 9, 2013
    Report Date
    April 17, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTO
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH VAGINA PROLAPSED, RECTOCELE, AND TRANSVAGINAL HYSTERECTOMY WITH PLANNED PRESERVATION OF OVARIES IF NON PATHOLOGICAL. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION, INFECTION, URINARY/BOWEL PROBLEMS, ORGAN PERFORATION, FISTULAE, RECURRENCE, BLEEDING, DYSPAREUNIA, NEUROMUSCULAR PROBLEMS AND VAGINAL SCARRING. ON (B)(6) 2011 THE PATIENT REPORTED THAT WITHIN ONE WEEK OF THE MESH IMPLANT SURGERY THE PATIENT HAD ALL OF HER UPPER TEETH REMOVED DUE TO INFECTION WITH ABCESS; EXTENDED INTO THE SINUSES DUE TO LEVEL OF INFECTION. THE PATIENT CONTINUED TO COMPLAIN ABOUT DIFFICULTY EVACUATING STOOL AND CONTINUES TO PRESS ON PERINEUM TO FACILITATE STOOLING. [SHE HAS AN EXCELLENT RECTOVAGINAL SEPTUM. THERE IS A SLIGHT DEFICIENCY OF THE PERINEAL BODY JUST LEFT TO THE MIDLINE AND THAT MAY BE THE AREA SHE PUSHES TO FACILITATE STOOLING.] [THE SURGEON IS PLANNING TO EXCISE EXPOSED MESH, AND TO REBUILD THE DEFICIENCY OF THE LEFT SIDE BODY OF PERINEUM] IT WAS REPORTED THAT PATIENT UNDERWENT MESH REVISION/REMOVAL ON (B)(6) 2011. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT GYNECOLOGICAL PROCEDURE ON (B)(6) 2011 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
    204327 GYNECARE GYNEMESH* PS MESH, SURGICAL, POLYMERIC OTO ETHICON, INC. NA DAP667

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention