BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS SPHINCTER 800 URINARY PROSTHESIS

    MDR report key: 3010296 · Received March 12, 2013

    Report

    Report Number
    2183959-2013-00742
    Event Type
    Injury
    Date Received
    March 12, 2013
    Report Date
    February 22, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    EZY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS NOT CLEAR WHETHER THE EVENTS REPORTED WERE ASSOCIATED WITH AMS OR NON-AMS DEVICES. SHOULD ADD'L INFO BECOME AVAILABLE REGARDING THIS EVENT, IT WILL BE RE-EVALUATED AND A F/U REPORT WILL BE SENT.

    Description of Event or Problem · 1

    RELATED TO MFR REPORT #2183959-2013-00743. IT WAS REPORTED IN THE JOURNAL OF SEXUAL MEDICINE THAT A RETROSPECTIVE REVIEW OF PTS WAS PERFORMED FOR PTS WHO HAD AN AUS PLACEMENT BETWEEN (B)(6) 2011 AND (B)(6) 2012. THIS STUDY REVIEWED PTS WHO HAD THEIR AUS BALLOONS PLACED USING A "HIGH BALLOON PLACEMENT BENEATH THE RECTUS ABDOMINUS MUSCLE." IT WAS NOTED THAT A TOTAL OF 46 PTS RECEIVED AN ARTIFICIAL URINARY SPHINCTER. EARLY POSTOPERATIVE COMPLICATIONS WERE NOTED; ONE PT HAD A SCROTAL HEMATOMA ANOTHER HAD URINARY RETENTION THAT RESOLVED AFTER 4 DAYS OF CATHETER DECOMPRESSION. IT WAS ALSO REPORTED THAT ONE AUS PT SUSTAINED AN EROSION OF A 3.5CM CUFF. NO OTHER REVISIONS OR REMOVALS WERE REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104476 AMS SPHINCTER 800 URINARY PROSTHESIS ARTIFICIAL URINARY SPHINCTER EZY AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R