BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS SPHINCTER 800 URINARY PROSTHESIS

    MDR report key: 3182233 · Received June 14, 2013

    Report

    Report Number
    2183959-2013-00877
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 16, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    MIP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUFF AND PUMP WERE ANALYZED: RESULTS INDICATE BOTH COMPONENTS PERFORMED WITHIN SPECIFICATIONS. PUMP CATALOG 72400098, SERIAL #(B)(4), EXPIRATION DATE: 02/27/2018. MFG DATE: 02/01/2013. SHOULD ADD'L INFO BECOME AVAILABLE REGARDING THIS EVENT IT WILL BE RE-EVALUATED AND A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    RELATED TO MFR REPORT# 2183959-2013-00878. PT WAS IMPLANTED WITH AN AUS DEVICE AND SPECTRA DEVICE (MALLEABLE PENILE PROSTHESIS) ON (B)(6) 2013. IT WAS REPORTED THAT THE PT HAD HIS AUS CUFF AND PUMP REMOVED AND REPLACED DUE TO URINARY RETENTION. A SUPRAPUBIC TUBE WAS PLACED, THEN AFTER CONSULTING ANOTHER PHYSICIAN, "IT WAS DETERMINED THAT THE CUFF WAS TOO DISTAL - THEY MOVED THE CUFF DOWN ON THE URETHRA SO IT WOULD NOT BE UNDER THE CONSTANT PRESSURE OF THE MALLEABLE CYLINDERS. IT WAS APPARENT THE SYS WAS WORKING AT THIS TIME." NO ADD'L PT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272129 AMS SPHINCTER 800 URINARY PROSTHESIS ARTIFICIAL URINARY SPHINCTER MIP AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R