BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH

    MDR report key: 3122956 · Received May 21, 2013

    Report

    Report Number
    2210968-2013-05734
    Event Type
    Injury
    Date Received
    May 21, 2013
    Report Date
    May 2, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2002 AND MESH WAS IMPLANTED. THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT PELVIC ORGAN PROLAPSE, CYSTOCELE, RECTOCELE, STRESS URINARY INCONTINENCE AND SYMPTOMATIC UTERINE PROLAPSE. IT WAS REPORTED THAT THE PATIENT HAD A CONCURRENT PROCEDURE OF A TOTAL ABDOMINAL HYSTERECTOMY / BILATERAL SALPINGO-OOPHORECTOMY SUPRAPUBIC CYSTOSCOPY, AND ANTERIOR POSTERIOR COLPORRHAPHY PERFORMED DURING MESH IMPLANTATION. THE PATIENT EXPERIENCED PAIN, EROSION OF INTERNAL BODILY TISSUE AND OTHER INJURIES, CHRONIC PELVIC AND VAGINAL AREA PAIN, URINE LEAKAGE, DIURNAL FREQUENCY AND URGENCY, VERY PAINFUL INTERCOURSE, VAGINAL DISCHARGE, PUNGENT VAGINAL ODOR, RECURRENCE OF PROLAPSE AND CONSTIPATION, SEVERE PAIN IN LOWER BACK AND DOWN LEGS INCLUDING HIPS AND KNEES, PHYSICAL PAIN AND DISCOMFORT, CAN FEEL PROTRUSION OF MESH IMPLANT, UNRELENTING PAIN, SEVERE INJURIES, INABILITY TO ENGAGE IN SEXUAL INTIMACY HAS TAKEN TOLL ON EMOTIONAL STATUS, SUFFERS FROM DEPRESSION DUE TO THE DECREASE IN OVERALL QUALITY OF LIFE, AND HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. IT WAS REPORTED THAT THE PATIENT UNDERWENT CYSTOMETROGRAM, VOIDING PRESSURE, URETHRAL PRESSURE PROFILE, CYSTOGRAM, CYSTOSCOPY, BILATERAL RETROGRADE PYELOGRAM, BLADDER HYDROSUSPENSION, AND BIOPSY SECONDARY TO MICRO HEMATURIA, NEUROGENIC BLADDER, DIURNAL URINARY FREQUENCY & URGENCY ON (B)(6) 2005. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    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). CONCLUSION: 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) 2005 AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF INTERNAL BODILY TISSUE AND OTHER INJURIES, AND 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
    223579 PROLENE POLYPROPYLENE MESH MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA RAE509

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention