BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS 700 INFLATABLE PENILE PROSTHESIS

    MDR report key: 1982713 · Received February 2, 2011

    Report

    Report Number
    2183959-2011-00060
    Event Type
    Injury
    Date Received
    February 2, 2011
    Date of Event
    June 29, 2010
    Report Date
    June 29, 2010
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FAE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ORIGINALLY IMPLANTED (B)(6) 2010 WITH AN IPP DEVICE. ON (B)(6) 2010, THE ENTIRE DEVICE WAS REMOVED DUE TO INFECTION AND EROSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMS 700 INFLATABLE PENILE PROSTHESIS IPP FAE AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R