BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS 700 INFLATABLE PENILE PROSTHESIS

    MDR report key: 2151557 · Received June 28, 2011

    Report

    Report Number
    2183959-2011-00229
    Event Type
    Injury
    Date Received
    June 28, 2011
    Date of Event
    February 19, 2010
    Report Date
    February 18, 2010
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FAE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG #: CYLINDERS AND PUMP: 72404232, RESERVOIR 72404155. SERIAL #: CYLINDERS AND PUMP (B)(4), RESERVOIR (B)(4). THE CYLINDERS, PUMP, AND RESERVOIR WERE RETURNED FOR ANALYSIS. THEY WERE ALL RATED AS PERFORMING WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    ON (B)(6) 2010, AN IPP WAS IMPLANTED. ON (B)(6) 2010, IT WAS REPORTED THAT A REVISION SURGERY WOULD BE NEEDED. ON (B)(6) 2010, THE ENTIRE DEVICE WAS REMOVED AND REPLACED DUE TO EROSION. NO PATIENT COMPLICATIONS REPORTED.

    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 55 YR Hospitalization| R