BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMS SPARC SLING SYSTEM

    MDR report key: 5343321 · Received January 5, 2016

    Report

    Report Number
    2183959-2016-00007
    Event Type
    Death
    Date Received
    January 5, 2016
    Date of Event
    March 27, 2009
    Report Date
    December 29, 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 Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED AGAINST AN INITIAL REPORT THAT WAS SUBMITTED UNDER THE PREVIOUS SITE REGISTRATION NUMBER (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PLAINTIFF'S ATTORNEY THAT THE PLAINTIFF ALLEGEDLY EXPERIENCED EMOTIONAL DISTRESS AND A PRODUCT PROBLEM. FURTHERMORE, THE PLAINTIFF DIED. NO CAUSE OF DEATH WAS REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PLAINTIFF'S ATTORNEY THAT THE PLAINTIFF ALLEGEDLY EXPERIENCED BURNING, BOWEL PROBLEMS, INFECTION, FISTULAE, RECURRENCE, URINARY TRACT INFECTION THAT CAUSED DISTRESS, CONFUSION, FALLING, EMBARRASSMENT DUE TO URINARY PROBLEMS, ACCIDENTS, AND ODOR. IT WAS ALSO REPORTED THAT THE PLAINTIFF EXPERIENCED URGE INCONTINENCE, URINARY RETENTION, LEAKING, BLADDER PAIN, VAGINAL TISSUE ATROPHY, UPPER WALL LAXITY, URETHRAL PROLAPSE, BLADDER SPASM, DEPRESSION AND ANXIETY, PAIN ON URINATION, CYSTOCELE, URGENCY, URETHRAL HYPERMOBILITY, INCOMPLETE BLADDER EMPTYING, URETHRAL DILATION, OBSTRUCTION, VOIDING DYSFUNCTION, DETRUSOR OVERACTIVITY, AND NOCTURIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3583 AMS SPARC SLING SYSTEM MESH, SURGICAL, POLYMERIC OTN ASTORA WOMEN'S HEALTH LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Death