BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMS 800 URINARY CONTROL SYSTEM

    MDR report key: 4454469 · Received January 27, 2015

    Report

    Report Number
    2183959-2015-00046
    Event Type
    Death
    Date Received
    January 27, 2015
    Date of Event
    October 30, 2014
    Report Date
    November 25, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS (MN)
    Product Code
    EZY
    PMA / PMN Number
    P000053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SERIAL NUMBER: (B)(4), CATALOG NUMBER: 72400161, COMPONENT EXPIRATION DATE: 08/12/2009, COMPONENT MANUFACTURE DATE: 08/30/2004. SERIAL NUMBER: (B)(4), CATALOG NUMBER: 72400098, COMPONENT EXPIRATION DATE: 01/27/2010, COMPONENT MANUFACTURE DATE: 02/14/2005. SERIAL NUMBER: (B)(4), CATALOG NUMBER: 72400024, COMPONENT EXPIRATION DATE: 05/04/2010, COMPONENT MANUFACTURE DATE: 05/20/2005. THE REPLACEMENT SURGERY WAS INITIALLY REPORTED ON (B)(4) 2014. THIS WAS INTENDED TO BE SENT ON (B)(4) 2014. EXEMPTION (B)(4). HOWEVER, ADDITIONAL INFORMATION WAS RECEIVED ON (B)(4) 2014 THAT INDICATED PATIENT DEATH WHICH NECESSITATED A MEDWATCH REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD HIS ARTIFICIAL URINARY SPHINCTER REMOVED AND REPLACED (B)(6) 2014 DUE TO UNSPECIFIED REASONS. IT WAS FURTHER REPORTED ON (B)(6) 2014 THAT THE REPLACEMENT SURGERY WAS DUE TO "EROSION: BULBAR URETHRA." THE PHYSICIAN INDICATED THE PATIENT'S OUTCOME WAS "DECEASED" DUE TO "MI." NO FURTHER COMPLICATIONS WERE REPORTED IN RELATION TO THIS REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61796 AMS 800 URINARY CONTROL SYSTEM ARTIFICIAL URINARY SPHINCTER EZY AMERICAN MEDICAL SYSTEMS (MN)

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death