BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS DURA II POSTIONABLE PENILE PROSTHESIS

    MDR report key: 9180330 · Received October 11, 2019

    Report

    Report Number
    2183959-2019-66774
    Event Type
    Injury
    Date Received
    October 11, 2019
    Date of Event
    September 26, 2019
    Report Date
    October 9, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FAE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED STEEL ROD FRACTURED ON BOTH RIGHT AND LEFT SIDES WITH A DURA II PENILE PROSTHESIS (DPP) FOR TRANSGENDER PROSTHESIS. THE DPP WAS EXPLANTED AND A SPECTRA PENILE PROSTHESIS (SPP) WAS IMPLANTED. FURTHER INFORMATION HAS BEEN REQUESTED AND NOT YET RECEIVED. 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
    974131 AMS DURA II POSTIONABLE PENILE PROSTHESIS PROSTHESIS PENILE FAE BOSTON SCIENTIFIC CORPORATION UNK-P-MPP

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R