BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE GYNEMESH* PS

    MDR report key: 3061849 · Received April 16, 2013

    Report

    Report Number
    2210968-2013-03951
    Event Type
    Injury
    Date Received
    April 16, 2013
    Report Date
    March 27, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTO
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    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. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ON (B)(6) 2005 IN ORDER TO TREAT PELVIC ORGAN PROLAPSE, URINARY INCONTINENCE, CYSTOCELE, RECTOCELE, AND URETHRAL HYPERMOBILITY. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES, AND SHE HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED CHRONIC PELVIC AND VAGINAL AREA PAIN, PAINFUL INTERCOURSE, CHRONIC PAIN WITH SITTING AND STANDING, URINARY RETENTION, URINARY LEAKAGE, URGENCY FREQUENCY WITH URINATION, CHRONIC ABDOMINAL CRAMPING, DIFFICULTY BOWEL MOVEMENTS, MESH EROSION, PROTRUSION, PUNGENT VAGINAL ODOR, AND DISCHARGE. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2012 DUE TO PAIN AND EROSION OF DUAL VAGINAL SLING. 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) 2006 AND MESH WAS 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
    162017 GYNECARE GYNEMESH* PS MESH, SURGICAL, POLYMERIC OTO ETHICON, INC. NA UKB552

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention