BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS SPHINCTER 800 URINARY PROSTHESIS

    MDR report key: 2850454 · Received November 15, 2012

    Report

    Report Number
    2183959-2012-03008
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    August 10, 2012
    Report Date
    August 21, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    EZY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG #: 72400024, 72400098. SERIAL #: (B)(4). EXPIRATION DATE: 10/25/2006, 10/30/2006. IMPLANTED: (B)(6) 2002. MANUFACTURED: 10/26/2001, 11/01/2001. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE REGARDING THIS EVENT, IT WILL BE RE-EVALUATED AND A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ARTIFICIAL URINARY SPHINCTER DEVICE (AUS) HAD A "MALFUNCTION" AND A "BREAK IN THE TUBING BETWEEN THE CUFF AND THE PUMP." THE AUS DEVICE WAS EXPLANTED AND REPLACED. NO PT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    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.

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R