BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFLATABLE PENILE PROSTHESIS

    MDR report key: 121206 · Received September 18, 1997

    Report

    Report Number
    2126328-1997-04140
    Event Type
    Injury
    Date Received
    September 18, 1997
    Date of Event
    December 10, 1996
    Report Date
    September 18, 1997
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FHW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE IPP DEVICE WAS REMOVED FROM THE PT DUE TO "MALFUNCTIONING"-EROSION OF CYLINDER INTO URETHRA. REFER TO ACCESS NUMBER 1011941.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFLATABLE PENILE PROSTHESIS Implant IPP FHW AMERICAN MEDICAL SYSTEMS, INC. 700 AN318 005,AN318 005, (MORE)

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R