BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMS INFLATABLE PENILE PROSTHESIS

    MDR report key: 10116674 · Received June 3, 2020

    Report

    Report Number
    2183959-2020-02412
    Event Type
    Malfunction
    Date Received
    June 3, 2020
    Date of Event
    May 14, 2020
    Report Date
    June 3, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FHW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT LIAISON SPOKE WITH THE PATIENT ON RECOMMENDATION OF LOCAL SALES REPRESENTATIVE. THE PATIENT IS UPSET BECAUSE HIS PUMP DOESN'T WORK AND CLAIMS THAT HE CAN'T SQUEEZE IT TO GET A POP. HE HAS TRIED THE TROUBLE SHOOTING MANEUVERS (TO INCLUDE THE BURP/ANTI-STICTION AND REBOOT) BUT WHEN HE PUSHES THE PUMP IT GOES FLAT AND STAYS FLAT. ANOTHER PIECE OF HIS FRUSTRATION IS THAT HE CAN NOT GET ANYONE FROM THE DRS OFFICE TO RETURN HIS CALL. THE SALES REPRESENTATIVE MET WITH THE PATIENT AND HE IS BEING SCHEDULED TO REPLACE THE IPP PUMP ONLY, UNLESS THERE IS A LEAK, WHICH THEY WILL REALIZE UNTIL THE PUMP IS EXPOSED IN THE OPERATING ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579459 AMS INFLATABLE PENILE PROSTHESIS DEVICE IMPOTENCE MECHANICAL/HYDRAULIC FHW BOSTON SCIENTIFIC CORPORATION UNK-P-IPP

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR