BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR

    MDR report key: 17636 · Received August 2, 1994

    Report

    Report Number
    17636
    Event Type
    Injury
    Date Received
    August 2, 1994
    Date of Event
    June 2, 1994
    Report Date
    June 17, 1994
    Manufacturer
    MENTOR O & O INC.
    Product Code
    FAE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT. RELATES LONG HISTORY OF PROBLEMS DEFLATING HIS PROSTHESIS. M.D. NOTED POSSIBLE EROSION OF PROSTHESIS LAST YEAR. RECENTLY ATIENT NOTED CONTINUAL INCREASING PROMINENCE, ESPECIALLY OF RT. CYLINDER. DUE TO EROSION OF PROSTHESIS, SURGERY WAS PERFORMED TO REMOVE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MENTOR Implant PENILE PROSTHESIS FAE MENTOR O & O INC. UNKNOWN 083582

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention