BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMS INFLATABLE PENILE PROSTHESIS

    MDR report key: 8883565 · Received August 12, 2019

    Report

    Report Number
    2183959-2019-65613
    Event Type
    Malfunction
    Date Received
    August 12, 2019
    Date of Event
    May 21, 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
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CLAIMS THAT NEITHER HE NOR THE DR. CAN GET THE INFLATABLE PENILE PROSTHESIS (IPP) TO INFLATE. THE PATIENT STATES THAT THE PUMP WILL PUMP, BUT THAT NO FLUID TRANSFERS. NO MORE INFORMATION IS AVAILABLE AT THE MOMENT, ADDITIONAL INFORMATION WAS REQUESTED AND WILL BE PROVIDED AS IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676931 AMS INFLATABLE PENILE PROSTHESIS DEVICE IMPOTENCE MECHANICAL/HYDRAULIC FHW BOSTON SCIENTIFIC CORPORATION UNK-P-IPP

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R