BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS SPECTRA CONCEALABLE PENILE PROSTHESIS

    MDR report key: 8748685 · Received July 1, 2019

    Report

    Report Number
    2183959-2019-64669
    Event Type
    Injury
    Date Received
    July 1, 2019
    Date of Event
    April 16, 2019
    Report Date
    July 1, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FAE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNSPECIFIED ISSUES WITH A SPECTRA PENILE PROSTHESIS (SPP). THE SPP WAS EXPLANTED AND A NEW INFLATABLE PENILE PROSTHESIS (IPP) WAS IMPLANTED. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE OR THE PRODUCT WAS RETURNED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF PRODUCT ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542169 AMS SPECTRA CONCEALABLE PENILE PROSTHESIS PROSTHESIS PENILE FAE BOSTON SCIENTIFIC CORPORATION UNK-P-SPP

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R