BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE GYNEMESH* PS

    MDR report key: 3140483 · Received May 31, 2013

    Report

    Report Number
    2210968-2013-06244
    Event Type
    Injury
    Date Received
    May 31, 2013
    Report Date
    May 8, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTO
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2004 AND MESH WAS IMPLANTED CONCURRENTLY WITH AN ANTERIOR COLPORRHAPHY DUE TO LARGE CYSTOCELE PARAVAGINAL DEFECT.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT ANTERIOR VAULT RECONSTRUCTION WITH MESH USING ANTERIOR ELEVATE ON (B)(6) 2009 DUE TO THIRD-DEGREE CYSTOCELE. IT WAS REPORTED THAT THE PATIENT UNDERWENT REPAIR OF CYSTOTOMY, ROBOTIC SACROCOLPOPEXY, EMPATHY (RESTORELLE) MESH IMPLANT ON (B)(6) 2010 DUE TO THIRD-TO FOURTH-DEGREE APICAL VAULT PROLAPSE.

    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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ON (B)(6) 2004. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN, URINARY PROBLEMS, BOWEL PROBLEMS, FISTULAE, RECURRENCE, AND VAGINAL SCARRING. IT WAS REPORTED THAT THE PATIENT UNDERWENT PARAVAGINAL REPAIR FOR MESH EXTRUSION AND CYSTOCELE ON (B)(6) 2008. IT WAS REPORTED THAT THE PATIENT UNDERWENT CYSTOSCOPY URETHROLYSIS ON (B)(6) 2008. IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY TO REPAIR BOWEL OBSTRUCTION ON (B)(6) 2010. (B)(4). 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 GYNECOLOGICAL PROCEDURES ON (B)(6) 2001, (B)(6) 2004, (B)(6) 2009 AND (B)(6) 2010 AND MESH, ALLOGRAFT, ELEVATE AND RESTORRELLE WERE IMPLANTED. THE DATES WERE NOT CLARIFIED PER PRODUCT. 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
    240725 GYNECARE GYNEMESH* PS MESH, SURGICAL, POLYMERIC OTO ETHICON, INC. NA SPE685

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention