BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS INFLATABLE PENILE PROSTHESIS

    MDR report key: 8883660 · Received August 12, 2019

    Report

    Report Number
    2183959-2019-65617
    Event Type
    Injury
    Date Received
    August 12, 2019
    Date of Event
    July 22, 2019
    Report Date
    August 12, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FHW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNSPECIFIED ISSUES WITH A PREVIOUS INFLATABLE PENILE PROSTHESIS (IPP). THE RESERVOIR WAS REMOVED AND REPLACED FOR A NEW 100 ML CONCEAL RESERVOIR. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT. NO MORE INFORMATION IS AVAILABLE AT THE MOMENT, ADDITIONAL INFORMATION WAS REQUESTED AND WILL BE PROVIDED AS IT BECOMES AVAILABLE. ADDITIONAL INFORMATION RECEIVED. THE RESERVOIR WAS REMOVED DUE TO PATIENT COMPLAINT OF PAIN. IT WAS DETERMINED THAT THE RESERVOIR MIGRATED. AFTER IMPLANTATION THE DEVICE CYCLED ADEQUATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678151 AMS INFLATABLE PENILE PROSTHESIS DEVICE IMPOTENCE MECHANICAL/HYDRAULIC FHW BOSTON SCIENTIFIC CORPORATION UNK-P-IPP

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R