BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA

    MDR report key: 1640222 · Received March 22, 2010

    Report

    Report Number
    2183959-2010-00146
    Event Type
    Injury
    Date Received
    March 22, 2010
    Date of Event
    March 18, 2010
    Report Date
    March 18, 2010
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    JCW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FREQUENCY OF OCCURRENCE OF THE EVENT IS ADDRESSED IN THE DEVICE LABELING. THE FREQUENCY FOR THIS EVENT IS NOT GREATER THAN IS USUAL.

    Description of Event or Problem · 1

    A (B) (6) MALE PT WITH VASCULAR DISEASE WAS IMPLANTED WITH A SPECTRA DEVICE ON (B) (6) 2009. ON (B) (6) 2010, THE SPECTRA DEVICE WAS REMOVED AND AN IPP DEVICE IMPLANTED DUE TO PT DISCOMFORT DUE TO CROSSOVER OF THE CYLINDERS. A REQUEST FOR THE DEVICE HAS BEEN MADE, NO FURTHER INFO HAS BEEN PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| R