BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE GYNEMESH* PS

    MDR report key: 2981188 · Received February 27, 2013

    Report

    Report Number
    2210968-2013-01845
    Event Type
    Injury
    Date Received
    February 27, 2013
    Report Date
    September 6, 2024
    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
    Health Professional
    N

    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. THIS IS ONE OF THREE MEDWATCHES BEING SUBMITTED. SEE ALSO MEDWATCH 2210968-2013-01844 AND MEDWATCH 2210968-2013-01843. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT ON (B)(6) 2011 THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE IN ORDER TO TREAT SYMPTOMATIC STAGE III PROLAPSE AND STRESS URINARY INCONTINENCE AND MESH WAS IMPLANTED. IT WAS REPORTED THAT ON (B)(6) 2011 THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE IN ORDER TO TREAT RECURRENT VAGINAL PROLAPSE AND MESH WAS IMPLANTED ALONG WITH THE CONCURRENT PROCEDURE OF A LAPAROSCOPIC ASSISTED SACRAL COLPOPEXY. IT WAS REPORTED THAT FOLLOWING INSERTION OF THE MESH THE PATIENT EXPERIENCED VAGINAL EROSION, RECURRENT URINARY INFECTIONS, WORSENING INCONTINENCE, WORSENING DYSPAREUNIA, CHRONIC VAGINAL PAIN, CHRONIC ABDOMINAL PAIN, VAGINAL SCARRING, BLOOD IN URINE, DYSURIA, POLYURIA, FREQUENT URINATION, PREVIOUS PLACED MESH ((B)(6) 2010) PULLED FREE FROM ATTACHMENT IN SACRUM, EROSION INTO THE GENITAL TRACT, RECURRENT PROLAPSE, HEMATURIA, HEMATOMA, ATROPHIC VAGINITIS, FISTULA AND ELEVATED WHITE COUNT. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REMOVAL, ABDOMINAL SACRAL COLOPEXY, RIGHT SALPINGO OOPHORECTOMY, REPAIR OF VAGINAL MESH EROSION AND CYSTOSCOPY ON (B)(6) 2011. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2012, (B)(6) 2012, AND (B)(6) 2012. (B)(4). IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOLLOW UP 01 BEING RESUBMITTED AS FOLLOW UP 01 AS REQUESTED BY ESG DUE TO A DB CONNECTION ISSUE THAT OCCURRED WHEN THE ORIGINAL SUBMISSION WAS MADE ON (B)(4) 2014. (B)(4). THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT STAGE III VAGINAL PROLAPSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGICAL PROCEDURES ON (B)(6) 2010 AND (B)(6) 2011 AND MESH WAS IMPLANTED INTO THE PATIENT. IT IS REPORTED THAT THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES, AND SHE HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83342 GYNECARE GYNEMESH* PS MESH, SURGICAL, POLYMERIC OTO ETHICON, INC. NA BKP214

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention NI.