BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE GYNEMESH* PS

    MDR report key: 3130088 · Received May 24, 2013

    Report

    Report Number
    2210968-2013-05909
    Event Type
    Injury
    Date Received
    May 24, 2013
    Report Date
    May 9, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTO
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY

    Narratives

    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

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ON (B)(6) 2006 IN ORDER TO TREAT PELVIC ORGAN PROLAPSE, STRESS URINARY INCONTINENCE, CYSTOCELE, AND RECTOCELE CONCURRENTLY WITH A TOTAL HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY WITH A CYSTOSCOPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). ON (B)(6) 2012 THE PATIENT UNDERWENT REVISIONS OF MESH. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REMOVAL WITH IMPLANTATION OF NEW DEVICE (NO INFORMATION ON THIS DEVICE) ON (B)(6) 2012 DUE TO UTEROVAGINAL PROLAPSE, CYSTOCELE, RECTOCELE AND STRESS URINARY INCONTINENCE. DURING THIS SURGERY, PATIENT ALSO UNDERWENT A HYSTERECTOMY. THIS IS NO FURTHER INFORMATION AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2006 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
    232501 GYNECARE GYNEMESH* PS MESH, SURGICAL, POLYMERIC OTO ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention