BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS MALLEABLE 600/650 PENILE PROSHESIS

    MDR report key: 1964049 · Received January 11, 2011

    Report

    Report Number
    2183959-2011-00040
    Event Type
    Injury
    Date Received
    January 11, 2011
    Date of Event
    September 28, 2010
    Report Date
    September 28, 2010
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FAE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE REGARDING THIS REVISION SURGERY, IT WILL BE RE-EVALUATED AND A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    A (B)(6) OLD MALE WITH SPINAL CORD TRAUMA WAS IMPLANTED WITH A MALLEABLE DEVICE ON (B)(6) 2006. ON (B)(6) 2010, THE MALLEABLE DEVICE WAS REMOVED AND AN IPP DEVICE WAS IMPLANTED REASON WAS NOT PROVIDED. AMS HAS REQUESTED ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMS MALLEABLE 600/650 PENILE PROSHESIS 600 FAE AMERICAN MEDICAL SYSTEMS, INC. MPP

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization| R