BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS 800 URINARY CONTROL SYSTEM W/INHIBIZONE

    MDR report key: 4221897 · Received November 3, 2014

    Report

    Report Number
    2183959-2014-00487
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    June 21, 2013
    Report Date
    October 14, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS (MN)
    Product Code
    EZY
    PMA / PMN Number
    P000053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL COMPONENTS: PUMP CATALOG NUMBER: 72404127, SERIAL NUMBER: (B)(4), EXPIRATION DATE: 04/29/2014, MANUFACTURE DATE: 05/13/2013; BALLOON CATALOG NUMBER: 72400024, SERIAL NUMBER: (B)(4), EXPIRATION DATE: 04/04/2018, MANUFACTURE DATE: 04/2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WENT TO THE EMERGENCY ROOM IN SERIOUS CONDITION WITHIN TWO DAYS AFTER HIS ARTIFICIAL URINARY SPHINCTER ORIGINAL IMPLANT AND HAD IT REMOVED BECAUSE OF INFECTION. IT WAS INDICATED THAT THE PATIENT WAS IN THE INTENSIVE CARE UNIT FOR NINE DAYS AND IN THE HOSPITAL FOR ALMOST TWO MORE MONTHS INCLUDING REHABILITATION FOLLOWING THE REMOVAL SURGERY. NO ADDITIONAL COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT. RELATED TO MANUFACTURER REPORT NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701025 AMS 800 URINARY CONTROL SYSTEM W/INHIBIZONE ARTIFICIAL URINARY SPHINCTER EZY AMERICAN MEDICAL SYSTEMS (MN)

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R INFLATABLE PENILE PROSTHESIS