BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFLATABLE PENILE PROSTHESIS

    MDR report key: 1600798 · Received February 3, 2010

    Report

    Report Number
    2183959-2010-00044
    Event Type
    Malfunction
    Date Received
    February 3, 2010
    Date of Event
    December 10, 2009
    Report Date
    February 3, 2010
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    JCW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2007 A (B)(6) OLD MALE WAS IMPLANTED WITH HIS THIRD PENILE IMPLANT, AN INFLATABLE PENILE PROSTHESIS. ON (B)(6) 2009 PT SAID HE IS HAVING "INFLATION ISSUES". A REVISION SURGERY HAS NOT BEEN DETERMINED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFLATABLE PENILE PROSTHESIS IPP JCW AMERICAN MEDICAL SYSTEMS, INC. IPP 516903005

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Disability