BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE GYNEMESH* PS

    MDR report key: 3080030 · Received April 26, 2013

    Report

    Report Number
    2210968-2013-04538
    Event Type
    Injury
    Date Received
    April 26, 2013
    Report Date
    March 4, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTO
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE DUE TO RECURRENCE OF STRESS URINARY INCONTINENCE AND HAD REMOVAL AND REPLACEMENT OF TENSION FREE VAGINAL TAPE (UN-IDENTIFIED PRODUCT) ON (B)(6) 2011. NO ADDITIONAL INFORMATION WAS PROVIDED.THIS IS ONE OF TWO FOLLOW-UP MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO FOLLOW-UP MEDWATCH 2210968-2013-01147. THE SAME PATIENT IS REPRESENTED IN EACH FOLLOW-UP MEDWATCH.

    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 TWO MEDWATCHES BEING SUBMITTED. SEE ALSO MEDWATCH 2210968-2012-01147. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    DATE SENT TO FDA: 05/10/2016.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A ROBOTIC LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY, SACROCOLPOPEXY, BILATERAL SALPINGECTOMY AND CYSTOURETHROSCOPY ON (B()6) 2011 FOR THE TREATMENT OF RECURRENT UTEROVAGINAL PROLAPSED AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED MULTIPLE COMPLICATIONS, INCLUDING EROSION, BLEEDING, INCONTINENCE, INFECTION, SWELLING, DIFFICULTY VOIDING, 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
    181383 GYNECARE GYNEMESH* PS MESH, SURGICAL, POLYMERIC OTO ETHICON, INC. NA DHE216

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention