BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMS 700 INFLATABLE PENILE PROSTHESIS

    MDR report key: 2487866 · Received March 6, 2012

    Report

    Report Number
    2183959-2012-00260
    Event Type
    Malfunction
    Date Received
    March 6, 2012
    Date of Event
    August 10, 2011
    Report Date
    March 6, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FAE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CYLINDER AND PUMP: LOT/SERIAL #: (B)(4). CATALOGUE#: 718314004. DATE OF MFG: 06/2011. CONCEAL RESERVOIR: LOT/SERIAL #: (B)(4). CATALOGUE#: 720185-01. DATE OF MFG: 7/2011.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PT WAS ORIGINALLY IMPLANTED WITH AN INFLATABLE PENILE PROSTHESIS (IPP) DEVICE. ON (B)(6) 2011, AMS RECEIVED INFORMATION FROM THE PT THE DEVICE WAS NOT FUNCTIONING. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED IF THE PT'S DEVICE HAS BEEN REVISED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Disability