BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE GYNEMESH* PS

    MDR report key: 3042435 · Received April 9, 2013

    Report

    Report Number
    2210968-2013-03620
    Event Type
    Injury
    Date Received
    April 9, 2013
    Report Date
    March 21, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTO
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ON (B)(6) 2006 IN ORDER TO TREAT PARAVAGINAL DEFECT, PROCIDENTIA UTERI/CUFF, VAGINAL REPAIR, VAGINAL SUSPENSION AND FIXATION WITH GRAFT, STRESS URINARY INCONTINENCE, RECTOCELE REPAIR, INSERTION OF A SYNTHETIC GRAFT WITH A SACROCOLPOPEXY, PARAVAGINAL DEFECT REPAIR, POSTERIOR REPAIR, MIXED URINARY INCONTINENCE, AND PELVIC ORGAN PROLAPSE. IT WAS REPORTED THAT THE PATIENT UNDERWENT THE CONCURRENT PROCEDURES OF SACRAL COLPOPEXY, PARAVAGINAL DEFECT REPAIR, POSTERIOR REPAIR, AND A CYSTOSCOPY. THE PATIENT EXPERIENCED MULTIPLE COMPLICATIONS, INCLUDING EROSION, FORMATION OF SCAR TISSUE, ADDITIONAL SURGERIES, AND NEUROLOGIC COMPROMISE TO HER STRUCTURES AND TISSUES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 07/12/2016. ADDITIONAL EVENT OR PROBLEM NARRATIVE: IT WAS REPORTED THAT PATIENT UNDERWENT MESH REVISION ON (B)(6) 2015 BY DR. (B)(6). ADDITIONAL INFORMATION: AGE/DATE OF BIRTH.

    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.IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2013-03618. 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) 2008 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. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146715 GYNECARE GYNEMESH* PS MESH, SURGICAL, POLYMERIC OTO ETHICON, INC. NA AEE499

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention