BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMS ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE

    MDR report key: 5454472 · Received February 23, 2016

    Report

    Report Number
    3011770902-2016-00088
    Event Type
    Death
    Date Received
    February 23, 2016
    Date of Event
    March 1, 2011
    Report Date
    June 27, 2012
    Manufacturer
    ASTORA WOMEN'S HEALTH LLC
    Product Code
    OTP
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PLAINTIFF'S ATTORNEY THAT THE PLAINTIFF ALLEGEDLY EXPERIENCED PAIN, VOIDING DIFFICULTIES AND EROSION. IT WAS REPORTED THAT IN (B)(6) 2011, THE PLAINTIFF NOTED OBSTRUCTIVE URINARY SYMPTOMS WITH HIGH POST VOID RESIDUALS. THE PLAINTIFF UNDERWENT A REVISION SURGERY AND THE MESH WAS EXCISED. THE PLAINTIFF ALSO ALLEGEDLY EXPERIENCED RECURRENCE OF SYMPTOMS SCARRING AND WILL CONTINUE TO SUFFER, HAVE PAIN, DISABILITY, IMPAIRMENT AND LOSS OF ENJOYMENT OF LIFE, THE INABILITY TO ENGAGE IN CHOSEN AND NECESSARY ACTIVITIES AND OTHER DAMAGES. FURTHERMORE, IT WAS REPORTED THAT THE PLAINTIFF DIED. THE CAUSES OF DEATH WERE REPORTED AS ACUTE RESPIRATORY FAILURE, CHRONIC OBSTRUCTIVE PULMONARY DISEASE AND PULMONARY FIBROSIS SECONDARY TO HYPOTHYROIDISM AND URINARY TRACT INFECTIONS. RELATED TO MFR # 3011770902-2016-00087.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111284 AMS ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE SURGICAL MESH OTP ASTORA WOMEN'S HEALTH LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death MINIARC