BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS INFLATABLE PENILE PROSTHESIS

    MDR report key: 2831700 · Received November 9, 2012

    Report

    Report Number
    2183959-2012-02992
    Event Type
    Injury
    Date Received
    November 9, 2012
    Date of Event
    July 31, 2012
    Report Date
    August 9, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    JCW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADD'L INFO BECOME AVAILABLE REGARDING THIS REVISION SURGERY, IT WILL BE RE-EVALUATED AND A F/U REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD HIS 15 CM INFLATABLE PENILE PROSTHESIS WITH 1.0CM REAR TIP EXTENDERS REMOVED DUE TO FLUID LOSS. A NEW 15CM AMS 700 LGX INFLATABLE PENILE PROSTHESIS DEVICE WITH 5.0CM REAR TIP EXTENDERS WAS THEN IMPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R