BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS SPECTRA CONCEALABLE PENILE PROSTHESIS

    MDR report key: 5497717 · Received March 14, 2016

    Report

    Report Number
    2183959-2016-00090
    Event Type
    Injury
    Date Received
    March 14, 2016
    Date of Event
    March 2, 2016
    Report Date
    March 2, 2016
    Manufacturer
    AMERICAN MEDICAL SYSTEMS (MN)
    Product Code
    FAE
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REAR TIP EXTENDER (RTE). SERIAL#: (B)(4). CATALOG#: 72404321. EXPIRATION DATE: 06/09/2020. MFR DATE: 06/2015.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD HIS SPECTRA PENILE PROSTHESIS CYLINDER REMOVED AND REPLACED DUE TO REAR TIP EXTENDER (RTE) DISCONNECTED FROM THE BACK OF CYLINDER. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154683 AMS SPECTRA CONCEALABLE PENILE PROSTHESIS PROSTHESIS, PENILE FAE AMERICAN MEDICAL SYSTEMS (MN)

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention