BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE

    MDR report key: 4221891 · Received November 3, 2014

    Report

    Report Number
    2183959-2014-00486
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    June 21, 2013
    Report Date
    October 14, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS (MN)
    Product Code
    FHW
    PMA / PMN Number
    N970012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESERVOIR CATALOG NUMBER: 720185-01, SERIAL NUMBER: (B)(4), EXPIRATION DATE: 05/23/2015, MANUFACTURE DATE: 06/2013.

    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 WENT TO THE EMERGENCY ROOM IN SERIOUS CONDITION WITHIN TWO DAYS AFTER HIS INFLATABLE PENILE PROSTHESIS ORIGINAL IMPLANT AND HAD IT REMOVED BECAUSE OF INFECTION. IT WAS INDICATED THAT THE PATIENT WAS IN THE INTENSIVE CARE UNIT FOR NINE DAYS AND IN THE HOSPITAL FOR ALMOST TWO MORE MONTHS INCLUDING REHABILITATION FOLLOWING THE REMOVAL SURGERY. NO ADDITIONAL COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT. RELATED TO MANUFACTURER REPORT NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700988 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