BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE GYNEMESH* PS

    MDR report key: 3053199 · Received April 11, 2013

    Report

    Report Number
    2210968-2013-03684
    Event Type
    Injury
    Date Received
    April 11, 2013
    Report Date
    March 22, 2013
    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

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT STRESS URINARY INCONTINENCE AND VAGINAL PROLAPSE. IT WAS REPORTED THAT THE PATIENT HAD THE CONCURRENT PROCEDURES OF A BILATERAL SACRAL SPINOUS FIXATION, CYSTOSCOPY WITH CALIBRATION PERFORMED DURING MESH IMPLANTATION. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED BLEEDING/SPOTTING; URINARY INCONTINENCE; PAIN AND PRESSURE IN VAGINA RADIATING TO BACK; CYSTOCELE; UTEROVAGINAL PROLAPSED; AND MESH EROSION. IT WAS REPORTED THAT PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2008 AND ON (B)(6) 2011 FOR BLEEDING AND MESH EROSION. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2005 AND MESH AND IVS TUNNELLER WERE IMPLANTED. 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
    155319 GYNECARE GYNEMESH* PS MESH, SURGICAL, POLYMERIC OTO ETHICON, INC. NA TPP296

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IVS TUNNELLER| IVS TUNNELLER