BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS SPECTRA CONCEALABLE PENILE PROSTHESIS

    MDR report key: 9314733 · Received November 13, 2019

    Report

    Report Number
    2183959-2019-67473
    Event Type
    Injury
    Date Received
    November 13, 2019
    Date of Event
    October 16, 2019
    Report Date
    November 13, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FAE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNSPECIFIED ISSUES WITH HIS SPECTRA CONCEALABLE PENILE PROSTHESIS (SPP). THE SPP WAS REMOVED FOR UNKNOWN REASON AND REPLACED WITH A TACTRA PENILE PROSTHESIS. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT. NO MORE INFORMATION IS AVAILABLE AT THE MOMENT, ADDITIONAL INFORMATION WAS REQUESTED AND WILL BE PROVIDED AS RELEVANT INFORMATION BECOMES AVAILABLE. ADDITIONAL INFORMATION RECEIVED. THE SPP WAS REMOVED DUE TO INFECTION. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1110265 AMS SPECTRA CONCEALABLE PENILE PROSTHESIS PROSTHESIS PENILE FAE BOSTON SCIENTIFIC CORPORATION UNK-P-SPP

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R