BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE

    MDR report key: 5733220 · Received June 17, 2016

    Report

    Report Number
    2183959-2016-00133
    Event Type
    Injury
    Date Received
    June 17, 2016
    Date of Event
    March 7, 2016
    Report Date
    April 20, 2016
    Manufacturer
    AMERICAN MEDICAL SYSTEMS (MN)
    Product Code
    FHW
    PMA / PMN Number
    N970012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMMON DEVICE NAME FROM PENILE PROSTHESIS TO DEVICE, IMPOTENCE, MECHANICAL/HYDRAULICPMA/510(K) FROM K821628 TO N970012.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD AN INFLATABLE PENILE PROSTHESIS AND EXPERIENCED A "CARDIAC EVENT" AND PULMONARY EMBOLUS ON THE SAME DAY THAT THE PATIENT WAS IMPLANTED WITH THE DEVICE. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND A TRANSESOPHAGEAL ECHO WAS PERFORMED SHOWING A ¿LARGE SADDLE PE.¿ MEDICATION WAS GIVEN IN THE FORM OF TISSUE PLASMINOGEN ACTIVATOR. THE EVENT WAS CONSIDERED RESOLVED ON (B)(6) 2016 AND THE PATIENT WAS DISCHARGED. IT WAS REPORTED THAT THE EVENT WAS CONSIDERED SERIOUS AND THAT THE ADVERSE EVENT WAS NOT DEVICE RELATED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388046 AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE DEVICE, IMPOTENCE, MECHANICAL/HYDRAULIC FHW AMERICAN MEDICAL SYSTEMS (MN)

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O