BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS INFLATABLE PENILE PROSTHESIS

    MDR report key: 5743197 · Received June 22, 2016

    Report

    Report Number
    2183959-2016-00134
    Event Type
    Injury
    Date Received
    June 22, 2016
    Date of Event
    May 27, 2016
    Report Date
    May 27, 2016
    Manufacturer
    AMERICAN MEDICAL SYSTEMS (MN)
    Product Code
    FHW
    PMA / PMN Number
    N970012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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.

    Additional Manufacturer Narrative · 1

    CYLINDERS AND PUMP MODEL 72404231, SERIAL (B)(4), MANUFACTURE DATE 08/26/2015 EXPIRATION DATE 08/10/2017. RESERVOIR MODEL 72404155, SERIAL (B)(4), MANUFACTURE DATE 03/25/2016, EXPIRATION DATE 03/11/2018. ANALYSIS RESULTS: THE TRIED, NOT USED INFLATABLE PENILE PROSTHESIS WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED. NO LEAK WAS FOUND. THE CYLINDERS, RESERVOIR, AND PUMP PERFORMED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INFLATABLE PENILE PROSTHESIS ORIGINAL IMPLANT SURGERY, THE PHYSICIAN GOT INTO THE ILIAC ARTERY AND THE CASE WAS ABORTED. NO COMPONENTS WERE IMPLANTED. NO FURTHER COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396085 AMS INFLATABLE PENILE PROSTHESIS DEVICE, IMPOTENCE, MECHANICAL/HYDRAULIC FHW AMERICAN MEDICAL SYSTEMS (MN)

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R