BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA CONCEALABLE PENILE PROSTHESIS

    MDR report key: 2072661 · Received April 21, 2011

    Report

    Report Number
    2183959-2011-00145
    Event Type
    Injury
    Date Received
    April 21, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 22, 2011
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FAE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CYLINDERS WERE RETURNED AND ANALYZED. ANALYSIS RATED CYLINDERS AS PERFORMING WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    RELATED TO MFR# 2183959-2011-00123. ON (B)(6) 2011 THE PHYSICIAN ATTEMPTED TO IMPLANT AN AMS SPECTRA PENILE PROSTHESIS. IT WAS STATED, "DIFFICULTY PLACING SECOND 12MM CYLINDER/ROD - DEFAULTED TO 9.5MM, CROSSOVER MAY HAVE OCCURRED, SUSPECTED URETHRAL TRAUMA/PERFORATION - CASE ABORTED." IT IS UNK WHICH DEVICE CAUSED THE CROSSOVER/URETHRAL TRAUMA. PT OUTCOME REPORTED TO BE "GOOD" - PT OFFERS NO COMPLAINTS; F/U APPOINTMENT WILL BE SCHEDULED IN (B)(6) 2011.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R