BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS SPECTRA CONCEALABLE PENILE PROSTHESIS

    MDR report key: 9375008 · Received November 26, 2019

    Report

    Report Number
    2183959-2019-67668
    Event Type
    Injury
    Date Received
    November 26, 2019
    Date of Event
    November 19, 2019
    Report Date
    November 26, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FAE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT REPLACEMENT SURGERY FOR THE REMOVAL AMS SPECTRA CONCEALABLE PENILE PROSTHESIS AND REPLACEMENT OF INFLATABLE PENILE PROSTHESIS DUE TO UNSPECIFIED REASON. ADDITIONAL INFORMATION RECEIVED STATED THAT THE PATIENT ONLY HAD ONE CYLINDER IN THE LEFT SIDE AND PREFERRED INFLATABLE CYLINDERS DUE TO A DISSATISFACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1169458 AMS SPECTRA CONCEALABLE PENILE PROSTHESIS PROSTHESIS PENILE FAE BOSTON SCIENTIFIC CORPORATION UNK-P-SPP

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R