BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA

    MDR report key: 1853302 · Received September 29, 2010

    Report

    Report Number
    2183959-2010-00357
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    August 16, 2010
    Report Date
    August 31, 2010
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FAE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FREQUENCY OF OCCURRENCE OF THE EVENT IS ADDRESSED IN THE DEVICE LABELING AND IS SUFFICIENTLY CAPTURED IN OUR RISK ANALYSIS. UNABLE TO CONFIRM IF THE EVENT IS RELATED TO A DEVICE MALFUNCTION, DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    A (B)(6) MALE, WITH VASCULAR DISEASE WAS IMPLANTED WITH AN SPECTRA MALLEABLE DEVICE ON (B)(6)2010. ON (B)(6)2010, THE SPECTRA DEVICE WAS REMOVED AND AN IPP DEVICE IMPLANTED, DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRA CONCEALABLE PENILE PROSTHESIS FAE AMERICAN MEDICAL SYSTEMS, INC. 7240074-02

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R