BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARK II INFLATABLE PENILE PROSTHESIS

    MDR report key: 91287 · Received May 16, 1997

    Report

    Report Number
    2125050-1997-00247
    Event Type
    Injury
    Date Received
    May 16, 1997
    Date of Event
    April 7, 1997
    Report Date
    May 16, 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 INFORMATION PROVIDED TO CO BY THE PHYSICIAN'S OFFICE , THE DEVICE WAS REMOVED DUE TO A "MALFUNCTION". ADDITIONALLY, IT WAS OBSERVED AT THE TIME OF THE SURGICAL REVISION THAT A "CYLINDER FAILED AT THE BLADDER JUNCTION". AS REPORTED TO CO, THE ENTIRE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER CO 2-PIECE INFLATABLE PENILE PROSTHESIS. 4/25/97 - UPON RECEIPT OF ADDITIONAL INFORMATION PROVIDED BY THE PHYSICIAN/SURGEON, HE STATED,... "THE MALFUNCTION INVOLVED A BREAK IN THE TUBING AT CYLINDER. THE PATIENT DID NOT EXPERIENCE ANY DIFFICULTY WITH THE DEVICE EXCEPT AFTER A LOSS OF FLUID IN THE SYSTEM".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARK II INFLATABLE PENILE PROSTHESIS Implant INFLATABLE PENILE PROSTHESIS FHW MENTOR UROLOGY, INC. NA E90060

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention