BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE

    MDR report key: 3927892 · Received July 10, 2014

    Report

    Report Number
    2183959-2014-00287
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    June 20, 2014
    Report Date
    June 11, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS (MN)
    Product Code
    FHW
    PMA / PMN Number
    N970012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    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.

    Additional Manufacturer Narrative · 1

    CYLINDERS AND PUMP: CATALOG #: 72404232, SERIAL #: (B)(4), EXPIRATION DATE: 10/12/2014, MANUFACTURE DATE: 10/2012. RESERVOIR: CATALOG #: 72404155, SERIAL #: (B)(4), EXPIRATION DATE: 09/01/2014, MANUFACTURE DATE: 09/2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD HIS IPP REMOVED DUE TO PUMP EXTRUSION AND INFECTION THROUGH THE SCROTUM. DAMAGE TO THE EPIGASTRIC ARTERY WAS REPORTED. THE PHYSICIAN PERFORMED A LAPAROTOMY TO STOP THE BLOOD FLOW. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL FIVE DAYS POST OPERATION. NO ADDITIONAL PATIENT COMPLICATIONS HAVE BEEN REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403502 AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE DEVICE, IMPOTENCE, MECHANICAL/HYDRAULIC FHW AMERICAN MEDICAL SYSTEMS (MN)

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R