BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS SPECTRA CONCEALABLE PENILE PROSTHESIS

    MDR report key: 3110976 · Received May 9, 2013

    Report

    Report Number
    2183959-2013-00816
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    October 4, 2011
    Report Date
    April 23, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FHW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION 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 THE ENTIRE DEVICE WAS REMOVED DUE TO AN UNSPECIFIED MALFUNCTION. NO PT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202610 AMS SPECTRA CONCEALABLE PENILE PROSTHESIS PENILE PROSTHESIS FHW AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R