BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE GYNEMESH* PS

    MDR report key: 3042678 · Received April 9, 2013

    Report

    Report Number
    2210968-2013-03552
    Event Type
    Injury
    Date Received
    April 9, 2013
    Report Date
    March 22, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTO
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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. 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 AS THREE DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2013-03543 AND MEDWATCH 2210968-2013-03548. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTED NARRATIVE: IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND MESH WAS IMPLANTED IN ORDER TO TREAT CYSTOCELE AND RECTOCELE, STRESS URINARY INCONTINENCE AND UTEROVAGINAL PROLAPSE. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE, EXTRUSION, INFECTION, URINARY PROBLEMS, BLEEDING, DYSPAREUNIA AND OTHER INJURIES FOLLOWING THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. IT WAS REPORTED THAT THE PATIENT UNDERWENT EXCISION OF EXPOSED MESH ON (B)(6) 2008 DUE TO MESH EXPOSURE. IT WAS REPORTED THAT THE PATIENT UNDERWENT EXCISION OF VAGINAL EPITHELIUM WITH EXPOSED MESH ON (B)(6) 2009 DUE TO MESH EXPOSURE IN THE ANTERIOR COMPARTMENT AND VAGINAL SPOTTING. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4): IT WAS REPORTED THAT THE PATIENT HAD THE CONCURRENT PROCEDURES OF A LAVH, BSO, SACRAL SPINOUS VAGINAL VAULT SUSPENSION, AND CYSTOSCOPY PERFORMED DURING MESH IMPLANTATION. IT WAS REPORTED THAT THE PATIENT UNDERWENT EXCISION OF VAGINAL EPITHELIUM WITH ADMIXED EXPOSED POLYPROPYLENE MESH ON (B)(6) 2008. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT CYSTOCELE AND RECTOCELE, STRESS URINARY INCONTINENCE AND UTEROVAGINAL PROLAPSE. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION, INFECTION, URINARY PROBLEMS, BLEEDING AND DYSPAREUNIA. IT WAS REPORTED THAT THE PATIENT UNDERWENT EXCISION OF EXPOSED MESH ON (B)(6) 2008 DUE TO MESH EXPOSURE. IT WAS REPORTED THAT THE PATIENT UNDERWENT EXCISION OF VAGINAL EPITHELIUM WITH EXPOSED MESH ON (B)(6) 2009 DUE TO MESH EXPOSURE IN THE ANTERIOR COMPARTMENT AND VAGINAL SPOTTING. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4). THIS IS ONE OF THREE MEDWATCHES BEING SUBMITTED AS THREE DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2013-03543 AND MEDWATCH 2210968-2013-03548. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147244 GYNECARE GYNEMESH* PS MESH, SURGICAL, POLYMERIC OTO ETHICON, INC. NA XCP995

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention