BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRA

    MDR report key: 1901536 · Received November 10, 2010

    Report

    Report Number
    2183959-2010-00415
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    October 29, 2010
    Report Date
    November 10, 2010
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FAE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. AMS HAS REQUESTED THE RETURN OF THE EXPLANTED DEVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE REGARDING THIS REVISION SURGERY, IT WILL BE RE-EVALUATED AND A FOLLOW-UP REPORT WILL BE SENT. THE FREQUENCY OF OCCURRENCE OF THE EVENT IS ADDRESSED IN THE DEVICE LABELING AND IS SUFFICIENTLY CAPTURED IN OUR RISK ANALYSIS.

    Description of Event or Problem · 1

    A (B)(6) MALE WITH POST PROSTATECTOMY WAS IMPLANTED WITH A SPECTRA MALLEABLE DEVICE ON (B)(6) 2010. ON (B)(6) 2010, THE SPECTRA DEVICE WAS REMOVED AND AN AMBICOR DEVICE WAS IMPLANTED DUE TO "DEVICE MALPOSITION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRA CONCEALABLE PENILE PROSTHESIS FAE AMERICAN MEDICAL SYSTEMS, INC. 720054-02

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R