BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS SPHINCTER 800 URINARY PROSTHESIS

    MDR report key: 2200832 · Received August 8, 2011

    Report

    Report Number
    2183959-2011-00291
    Event Type
    Injury
    Date Received
    August 8, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 26, 2011
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    EZY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG#: BALLOON 72400024. PUMP 72404127. SERIAL#: BALLOON (B)(4). PUMP (B)(4). 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

    PT ORIGINALLY IMPLANTED ON (B)(6) 2007. THE ENTIRE DEVICE WAS REMOVED ON (B)(6) 2010 DUE TO EROSION. THERE WAS EXTENSIVE DEBRIDEMENT DONE DUE TO NECROTIZING FASCITIS GANGRENE. ON (B)(6) 2011, THE PT UNDERWENT AN ADD'L PROCEDURE FOR WOUND DEBRIDEMENT AND "MOBILIZATION OF SCROTAL AND MEDIAL PERINEAL TISSUE WITH CLOSURE OF WOUND." ON (B)(6) 2011, THE AUS DEVICE WAS REIMPLANTED. ON (B)(6) 2011, THE ENTIRE DEVICE WAS REMOVED DUE TO URETHRA EROSION WITH NECROTIZING FASCITIS OF THE PELVIS, LOWER ABDOMEN AND URETHRAL LACERATION.

    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 72 YR Hospitalization| R