BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE

    MDR report key: 4054558 · Received September 3, 2014

    Report

    Report Number
    2183959-2014-00384
    Event Type
    Injury
    Date Received
    September 3, 2014
    Date of Event
    August 18, 2014
    Report Date
    August 25, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS (MN)
    Product Code
    FHW
    PMA / PMN Number
    N970012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED: COMMON DEVICE NAME FROM PENILE PROSTHESIS TO DEVICE, IMPOTENCE, MECHANICAL/HYDRAULIC. PRODUCT CODE (FDA) FROM FAE TO FHW. THE PMA/510(K) FROM K821628 TO N970012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD HIS INFLATABLE PENILE PROSTHESIS RESERVOIR REPLACED DUE TO RENAL INSUFFICIENCY. PATIENT HAD A PREVIOUS KIDNEY TRANSPLANT. DURING THE IMPLANT OF THE INFLATABLE PENILE PROSTHESIS, THE PHYSICIAN "PLACED THE 65 ML SPHERICAL RESERVOIR ON THE SAME SIDE AS THE TRANSPLANT (SINCE THE OTHER SIDE HAD HERNIA MESH). THIS CAUSED THE PATIENT TO GO INTO RENAL INSUFFICIENCY." A PROCEDURE THEN OCCURRED TO REPLACE AND REPOSITION A NEW RESERVOIR "AWAY FROM THE TRANSPLANT BUT SAME SIDE AS MESH BEHIND THE PUBIC BONE, SLIGHTLY MEDIAL TO HERNIA REPAIR". NO FURTHER PATIENT COMPLICATIONS WERE REPORTED IN RELATION WITH THIS EVENT. PATIENT OUTCOME: "THE PATIENT APPEARS TO BE BETTER AT THIS TIME".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537724 AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE DEVICE, IMPOTENCE, MECHANICAL/HYDRAULIC FHW AMERICAN MEDICAL SYSTEMS (MN)

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R