BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMS MONARC SLING SYSTEM

    MDR report key: 5789755 · Received July 13, 2016

    Report

    Report Number
    3011770902-2016-00302
    Event Type
    Death
    Date Received
    July 13, 2016
    Date of Event
    December 13, 2013
    Report Date
    September 14, 2015
    Manufacturer
    ASTORA WOMEN'S HEALTH LLC
    Product Code
    OTN
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS WAS INITIALLY REPORTED ON THE SUMMARY REPORT DATED 12/28/2015 UNDER EXEMPTION E2013032

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE PLAINTIFF'S ATTORNEY THAT THE PLAINTIFF EXPERIENCED MESH EXPOSURE, STAGE 2 URETHROCELE, CYSTOCELE, RECTOCELE, VAGINAL CUFF PROLAPSE WITH ENTEROCELE, VAGINAL VAULT PROLAPSE, LEAKAGE, PELVIC PRESSURE, DYSPAREUNIA, VAGINAL BULGING, INCOMPLETE EMPTYING OF THE BLADDER, SEVERE NOCTURIA, MIXED URINARY INCONTINENCE, URETHRAL HYPERMOBILITY, URGENCY, FREQUENCY, NEUROGENIC DIFFUSE HYPERACTIVITY, BLADDER TRABECULATIONS, POST VOID DRIBBLING, ATROPHIC VAGINA, ERYTHEMA, DISORDERS OF UROGENITAL IMPLANTS, VAGINAL PAIN, AND MESH EROSION. THE PLAINTIFF UNDERWENT MESH EXCISION. THE DEVICE WAS PARTIALLY EXPLANTED. FURTHERMORE, IT WAS REPORTED THAT THE PLAINTIFF DIED. NO CAUSE OF DEATH WAS REPORTED. RELATED TO PR#: 123109

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PLAINTIFF'S CAUSES OF DEATH WERE REPORTED AS SEVERE CHRONIC OBSTRUCTIVE PULMONARY DISEASE, HYPERLIPIDEMIA, HYPERTENSION, DIABETES MELLITUS AND OBSTRUCTIVE SLEEP APNEA.

    Description of Event or Problem · 1

    RELATED TO MANUFACTURER REPORT #: 3011770902-2016-00303.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444518 AMS MONARC SLING SYSTEM MESH, SURGICAL, POLYMERIC OTN ASTORA WOMEN'S HEALTH LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death ELEVATE ANTERIOR