BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE GYNEMESH* PS

    MDR report key: 3172600 · Received June 17, 2013

    Report

    Report Number
    2210968-2013-06751
    Event Type
    Injury
    Date Received
    June 17, 2013
    Report Date
    May 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
    MD, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    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 CONCURRENTLY WITH BILATERAL SALPINGO-OOPHORECTOMY, ABDOMINAL COLPOSACROPEXY, BURCH, PARAVAGINAL REPAIR, DEFECT DIRECTED POSTERIOR COLPORRHAPHY AND CYSTOSCOPY DUE TO PELVIC ORGAN PROLAPSE, CYSTOCELE, RECTOCELE AND STRESS URINARY INCONTINENCE. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REMOVAL, EXPLORATORY LAPAROTOMY, TAKE DOWN OF FISTULA, SIGMOID COLOSTOMY AND HARTMANN¿S PATCH ON (B)(6) 2011 FOR COLORECTAL VESICLE AND VAGINAL FISTULA. ON (B)(6) 2011, THE PATIENT UNDERWENT MESH REMOVAL FOR FRAGMENTATION OF FOREIGN BODY BLADDER STONE AND EROSION OF MESH INTO THE BLADDER. ON (B)(6) 2012, THE PATIENT UNDERWENT MESH REMOVAL BY CYSTOSCOPY WITH LASER FRAGMENTATION FOR MESH IN THE BLADDER FRAGMENTS.

    Additional Manufacturer Narrative · 1

    THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT STRESS URINARY INCONTINENCE AND PELVIC ORGAN PROLAPSE. THE OUTCOMES ATTRIBUTED TO THE DEVICE WERE PAIN, EROSION, EXTRUSION, FISTULAE, RECURRENCE, VAGINAL SCARRING, ORGAN PERFORATION, BLADDER STONES, URINARY PROBLEMS, AND BOWEL PROBLEMS. IT WAS REPORTED THAT THE PATIENT UNDERWENT EXCISION OF ERODED MESH ON (B)(6) 2011 AND (B)(6) 2012. (B)(4).

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2004 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
    272775 GYNECARE GYNEMESH* PS MESH, SURGICAL, POLYMERIC OTO ETHICON, INC. NA SME232

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention