BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESKA JONAS SILICON-SILVER PENILE PROSTHESIS

    MDR report key: 19265 · Received October 20, 1994

    Report

    Report Number
    2182997-1994-00212
    Event Type
    Injury
    Date Received
    October 20, 1994
    Date of Event
    June 22, 1994
    Report Date
    September 27, 1994
    Manufacturer
    ESKA MEDICAL GMBH, & CO.
    Product Code
    FAE
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT. HAD PENILE PROSTHESIS PLACED AT UNKNOWN FACILITY 9/27/81. ON 6/22/94, HE PRESENTED TO HIS DR. WITH COMPLAINTS OF PAIN IN HIS PENIS AND FAILURE OF THE PROSTHESIS TO ACHEIVE ERRECTION. EXAM REVEALED THE PROSTHESIS PROTRUDED INTO THE RIGHT GLANS PENIS. SURGERY WAS PERFORMED 7/18/94 TO REM OVE THE PROSTHESIS, REPAIR THE CORPORAA CAVERNOSA AND REPLACE WITHA NEW PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESKA JONAS SILICON-SILVER PENILE PROSTHESIS Implant PENILE PROSTHESIS, SEMI-RIGID FAE ESKA MEDICAL GMBH, & CO. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention