BEUDAMED
    FDA Adverse Event Other Summary report: N

    AMS 700 CX MS PUMP

    MDR report key: 18845078 · Received March 6, 2024

    Report

    Report Number
    18845078
    Event Type
    Other
    Date Received
    March 6, 2024
    Date of Event
    February 8, 2024
    Report Date
    February 22, 2024
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FHW
    Report Source
    User Facility report
    Reporter Location
    TN
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PENILE IMPLANT REMOVED ON [DATE REDACTED]. IPP (IMPLANTABLE PENILE IMPLANT) PLACED 5 YEARS PRIOR, NOW WITH A SLOW LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119561 AMS 700 CX MS PUMP DEVICE, IMPOTENCE, MECHANICAL/HYDRAULIC FHW AMERICAN MEDICAL SYSTEMS, INC. 72404238 1000197145

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male