BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFLATABLE PENILE PROSTHESIS

    MDR report key: 105231 · Received July 15, 1997

    Report

    Report Number
    2125050-1997-00392
    Event Type
    Injury
    Date Received
    July 15, 1997
    Date of Event
    June 16, 1997
    Report Date
    June 18, 1997
    Manufacturer
    MENTOR UROLOGY, INC.
    Product Code
    FHW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PER THE INFO PROVIDED TO CO BY THE PHYSICIAN'S OFFICE, THE DEVICE WAS REMOVED DUE TO "MALFUNCTION", SECONDARY TO "TUBES BROKEN AT CONNECTOR(S)". AS REPORTED TO CO, THE ENTIRE MENTOR MFG 3-PIECE INFLATABLE PENILE PROSTHESIS WAS REMOVED AND REPLACED WITH ANOTHER MENTOR 3-PIECE DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention