BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS SPHINCTER 800 URINARY PROSTHESIS

    MDR report key: 2172603 · Received July 19, 2011

    Report

    Report Number
    2183959-2011-00249
    Event Type
    Injury
    Date Received
    July 19, 2011
    Date of Event
    November 6, 2009
    Report Date
    November 6, 2009
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    EZY
    Removal / Correction Number
    Z-2669-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO: CATALOG #: BALLOON 72400024, PUMP 72404127. SERIAL #: BALLOON (B)(4), PUMP (B)(4). SHOULD ADDITIONAL INFO BECOMES AVAILABLE REGARDING THIS EVENT, IT WILL BE RE-EVALUATED AND A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ON (B)(6) 2009, AN AUS DEVICE WAS IMPLANTED. THE PHYSICIAN INDICATED THAT, "WE DID HAVE A PT WHERE WE EXPERIENCED PROBLEMS WITH DEACTIVATION IN THE POST OPERATIVE PERIOD. HE WENT INTO RETENTION AND NEEDED SUPRAPUBIC CATHETER. THIS WAS REMOVED SUBSEQUENTLY WHEN WE "ACTIVATED" HIS SPHINCTER. THE PT IS DOING WELL SINCE THEN." IT WAS STATED THAT THE PT BEGAN EXPERIENCING ISSUES WITHIN 24 HOURS OF THE INITIAL SURGERY. FURTHER FOLLOW UP ON (B)(6) 2011 INDICATES, THE PT STATUS IS GOOD AND THE PHYSICIAN HAS A FOLLOW UP APPOINTMENT SOON WITH THE PT.

    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