BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX UGYTEX PP ANTERIOR KIT X1

    MDR report key: 2091534 · Received April 20, 2011

    Report

    Report Number
    9615742-2011-00023
    Event Type
    Injury
    Date Received
    April 20, 2011
    Date of Event
    March 29, 2007
    Report Date
    March 23, 2011
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    PMA / PMN Number
    K051503
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MDR REF #: 9615742-2009-00030 (AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM). BARD MDR REF#: (B)(4) (WHICH CORRESPONDS TO BARD COMPLAINT (B)(4) DESCRIBED AS "UNKNOWN SOFRADIM PRODUCT").

    Description of Event or Problem · 1

    PROCEDURE: UROLOGICAL AND GYNECOLOGICAL. ACCORDING TO THE REPORTER AND OTHER ADDITIONAL INFORMATION RECEIVED: THE PATIENT UNDERWENT A TOTAL ABDOMINAL HYSTERECTOMY WITH ANTERIOR AND POSTERIOR COLPORRHAPHY WITH AVAULTA ANTERIOR AND POSTERIOR GRAFT ALONG A TRANSOBTURATOR SLING AND EXCISION OF RECTAL SKIN TAGS. THE PREOPERATIVE AND POSTOPERATIVE DIAGNOSIS WERE PELVIC ORGAN PROLAPSE, RECTAL SKIN TAGS AND PELVIC PAIN. THE ADMITTING DIAGNOSIS WAS SYMPTOMATIC UTERINE PROLAPSE, CHRONIC PELVIC PAIN, SYMPTOMATIC CYSTOCELE AND RECTOCELE, AND STRESS URINARY INCONTINENCE. THE PREADMISSION HISTORY AND PHYSICAL REPORT INDICATED A FREELY MOBILE UTERUS AT SECOND TO THIRD DEGREE UTERINE PROLAPSE, SECOND DEGREE CYSTOCELE, RECTOCELE, AND NO ENTEROCELE. THE PATIENT UNDERWENT SUBSEQUENT SURGERIES ON (B)(6), 2007, AND ON (B)(6), 2009, AT WHICH TIME, THE VAGINAL GRAFT WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARIETEX UGYTEX PP ANTERIOR KIT X1 AVAULTA ANTERIOR BIOSYNTHETIC SYST. FTL SOFRADIM PRODUCTION UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other| R