BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS SPECTRA CONCEALABLE PENILE PROSTHESIS

    MDR report key: 9474088 · Received December 16, 2019

    Report

    Report Number
    2183959-2019-68134
    Event Type
    Injury
    Date Received
    December 16, 2019
    Date of Event
    November 25, 2019
    Report Date
    December 16, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FAE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DUE TO AN UNSPECIFIED REASON THE PATIENT HAD HIS SPECTRA PENILE PROSTHESIS (SPP) REMOVED AND REPLACED. THE SPP WAS EXPLANTED AND A TACTRA PENILE PROSTHESIS CONSISTING OF A 13 MM X 18 CM CYLINDERS WERE IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1267189 AMS SPECTRA CONCEALABLE PENILE PROSTHESIS PROSTHESIS PENILE FAE BOSTON SCIENTIFIC CORPORATION UNK-P-SPP

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R