BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALPHA I INFLATABLE PENILE PROSTHESIS

    MDR report key: 81693 · Received April 8, 1997

    Report

    Report Number
    2125050-1997-00173
    Event Type
    Injury
    Date Received
    April 8, 1997
    Date of Event
    March 7, 1997
    Report Date
    April 8, 1997
    Manufacturer
    MENTOR UROLOGY, INC.
    Product Code
    FHW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS REMOVED DUE TO A "TUBING LEAK BETWEEN THE PUMPS AND CYLINDER(S)". AS REPORTED TO CO, THE PUMP AND SOME ASSEMBLY KIT COMPONENT(S) ONLY WERE REMOVED AND REPLACED; LEAVING THE CYLINDER(S). CATALOG #9914S, SERIAL #133660 AND RESERVOIR, CATALOG #9060K, SERIAL #163066 IN PLACE FROM THE INITIAL IMPLANT SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALPHA I INFLATABLE PENILE PROSTHESIS Implant INFLATABLE PENILE PROSTHESIS FHW MENTOR UROLOGY, INC. NA E90075/R90090

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention