BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALPHA I INFLATABLE PENILE PROSTHESIS

    MDR report key: 82829 · Received April 11, 1997

    Report

    Report Number
    82829
    Event Type
    Injury
    Date Received
    April 11, 1997
    Date of Event
    February 21, 1997
    Report Date
    April 11, 1997
    Manufacturer
    MENTOR UROLOGY, INC.
    Product Code
    FHW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    REPORT, IT STATED, "REMOVAL OF NON-FUNCTIONING PENILE PROSTHESIS." AS REPORTED TO CO, THE CONNECTOR(S) ONLY WERE REMOVED AND REPLACED; LEAVING IN PLACE THE PUMP/CYLINDER SET, CATALOG #9918S, SERIAL #140773 AND RESERVOIR COMPONENT, CATALOG #9075K, SERIAL #148642 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 R90215

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention