BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS SPHINCTER 800 URINARY PROSTHESIS

    MDR report key: 3010304 · Received March 12, 2013

    Report

    Report Number
    2183959-2013-00741
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    October 8, 2012
    Report Date
    November 21, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    MIP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG #: 72400024, 72400098, 72400160; EXPIRATION DATE: 08/06/2003, 11/24/2003, 09/24/2008; SERIAL#: (B)(4); MANUFACTURE DATE: 07/1998, 11/1998, 09/2003. (B)(4). IMPLANTED (B)(6) 1998, (B)(4), IMPLANTED (B)(6) 2003. 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 DEVICE WAS REMOVED DUE TO RECURRING INCONTINENCE, AND "INCOMPLETE COAPTATION OF HIS DISTAL CUFF".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104739 AMS SPHINCTER 800 URINARY PROSTHESIS ARTIFICAL URINARY SPHINCTER MIP AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R UROLOME