BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS MALLEABLE PENILE IMPLANT

    MDR report key: 1201501 · Received October 17, 2008

    Report

    Report Number
    2125050-2008-00008
    Event Type
    Injury
    Date Received
    October 17, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 17, 2008
    Manufacturer
    COLOPLAST MANUFACTURING US LLC
    Product Code
    FAE
    PMA / PMN Number
    K040959
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECENTLY RECEIVED, AND FINAL EVAL RESULTS ARE IN-PROCESS. ADDITIONAL INFO WILL BE PROVIDED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    AS REPORTED TO COLOPLAST, "DEVICE BROKEN" IN 2008, AND EXPLANTED IN '08.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESIS MALLEABLE PENILE IMPLANT PENILE PROSTHESIS FAE COLOPLAST MANUFACTURING US LLC 710NM1730N 753892

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention