BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFLATABLE PENILE PROSTHESIS

    MDR report key: 1601133 · Received February 1, 2010

    Report

    Report Number
    2183959-2010-00042
    Event Type
    Malfunction
    Date Received
    February 1, 2010
    Date of Event
    December 9, 2009
    Report Date
    February 1, 2010
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    JCW
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2009 PT WAS IMPLANTED WITH AN IPP DEVICE. ON (B)(6) 2009 INFO RECEIVED INDICATES PT'S DEVICE WAS NON FUNCTIONING, POSSIBLY DUE TO PUMP FAILURE. ON (B)(6) 2009 THE IPP PUMP AND CYLINDERS WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFLATABLE PENILE PROSTHESIS IPP JCW AMERICAN MEDICAL SYSTEMS, INC. IPP 556521001

    Patients

    Seq Age Sex Outcome Treatment
    1 107 YR Hospitalization| R