BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS DURA II POSTIONABLE PENILE PROSTHESIS

    MDR report key: 8799023 · Received July 17, 2019

    Report

    Report Number
    2183959-2019-65073
    Event Type
    Injury
    Date Received
    July 17, 2019
    Date of Event
    June 10, 2019
    Report Date
    July 17, 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

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DUE TO A BROKEN CYLINDER THE PATIENT HAD HIS MALLEABLE PENILE PROSTHESIS (MPP) REMOVED AND REPLACED. THE MPP WAS EXPLANTED AND A NEW INFLATABLE PENILE PROSTHESIS (IPP) CONSISTING OF A 18CMX12MM CYLINDER, PUMP AND RESERVOIR WERE IMPLANTED. ONE OF THE PREVIOUS MPP CYLINDERS WAS LEFT IN PLACE AND A DEACTIVATION PLUG WAS PLACED IN TUBING. THE OLD MPP WAS IMPLANTED IN 2004.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593419 AMS DURA II POSTIONABLE PENILE PROSTHESIS PROSTHESIS PENILE FAE BOSTON SCIENTIFIC CORPORATION UNK-P-MPP

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R