BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS SPECTRA CONCEALABLE PENILE PROSTHESIS

    MDR report key: 2940565 · Received January 30, 2013

    Report

    Report Number
    2183959-2013-00502
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    January 1, 2012
    Report Date
    December 31, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FHW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS: THE DEVICE PERFORMED AND OPERATED ACCORDING TO SPECIFICATIONS. SHOULD ADDITIONAL INFO BECOME AVAILABLE REGARDING THIS EVENT IT WILL BE RE-EVALUATED AND A FOLLOW-UP REPORT WILL BE SENT AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE MONTH FOLLOWING THE IMPLANT, THE PT EXPERIENCED DISCHARGE FROM THE INCISION SITE. THE PT WAS DIAGNOSED WITH AN INFECTION. THE DEVICE WAS REMOVED ON AN UNDISCLOSED DATE. THE PT WAS REIMPLANTED WITH A SPECTRA CONCEALABLE PENILE PROSTHESIS ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40320 AMS SPECTRA CONCEALABLE PENILE PROSTHESIS PENILE PROSTHESIS FHW AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R