BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS SPHINCTER 800 URINARY PROSTHESIS

    MDR report key: 2172602 · Received July 19, 2011

    Report

    Report Number
    2183959-2011-00250
    Event Type
    Injury
    Date Received
    July 19, 2011
    Report Date
    June 21, 2011
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    EZY
    Removal / Correction Number
    Z-2669-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFO BECOME AVAILABLE REGARDING THIS EVENT, IT WILL BE REEVALUATED AND A F/U REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ON (B)(6) 2010 AN AUS WAS IMPLANTED. ON (B)(6) 2011, IT WAS REPORTED: "EVENT DATE: UNK. EVENT DESCRIPTION: PUMP ACTIVATED ITSELF, PT ATTENDED EMERGENCY DEPT WHERE IT WAS DE-ACTIVATED. HE RETURNED HOME AND IT RE-ACTIVATED AGAIN. PT DECIDED TO CATHETERIZE HIMSELF AND PERFORATED HIS URETHRA. HE ATTENDED ER AGAIN. ACTION TAKEN TO RESOLVE: REMOVED. PT OUTCOME: PT CURRENTLY HAS A SUPERPUBIC CATHETER IN PLACE." IT IS UNK IF THE ENTIRE DEVICE WAS REMOVED OR IF CERTAIN COMPONENTS WERE REMOVED. AMS HAS REQUESTED ADDITIONAL INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMS SPHINCTER 800 URINARY PROSTHESIS ARTIFICIAL URINARY SPHINCTER EZY AMERICAN MEDICAL SYSTEMS, INC. AUS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R