BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA

    MDR report key: 1873038 · Received October 14, 2010

    Report

    Report Number
    2183959-2010-00364
    Event Type
    Injury
    Date Received
    October 14, 2010
    Date of Event
    July 29, 2010
    Report Date
    October 7, 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

    UNABLE TO CONFIRM IF THE EVENT IS RELATED TO A DEVICE MALFUNCTION, DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS AND REASON PROMPTING THIS EVENT WAS NOT PROVIDED. ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION AND THE RETURN OF THE EXPLANTED PRODUCT. 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

    ON (B)(6) 2009, A (B)(6) OLD, MALE, WAS IMPLANTED WITH AN SPECTRA MALLEABLE DEVICE. ON (B)(6) 2010, THE SPECTRA DEVICE WAS REMOVED AND AN IPP DEVICE WAS IMPLANTED, REASON NOT PROVIDED. AMS IS ATTEMPTING TO OBTAIN ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRA CONCEALABLE PENILE PROSTHESIS FAE AMERICAN MEDICAL SYSTEMS, INC. 720074-03

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R