BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARK II INFLATABLE PENILE PROSTHESIS

    MDR report key: 46675 · Received November 5, 1996

    Report

    Report Number
    2125050-1996-00562
    Event Type
    Injury
    Date Received
    November 5, 1996
    Date of Event
    September 24, 1996
    Report Date
    November 5, 1996
    Manufacturer
    MENTOR UUROLOGY, INC.
    Product Code
    FHW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE AVAILABLE INFO THIS INFLATABLE PENILE PROSTHESIS WAS IMPLANTED ON 9/29/89 AND REVISED ON 9/24/96 DUE TO A "TUBING FRACTURE." REQUESTS FOR THE EXPLANTED PROSTHESIS AND FOR ADD'L INFO SURROUNDING THIS EVENT HAVE BEEN MADE, HOWEVER, TO DATE NEITHER THE DEVICE NOR THE INFO HAVE BEEN RECEIVED. WITHOUT THE BENEFIT OF ANALYZING THE EXPLANT AND WITHOUT THE REQUESTED INFO, QA IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE EVENTS SURROUNDING THIS INCIDENT. SHOULD THE EXPLANTED DEVICE OR ADD'L INFO BE RECEIVED, QA WILL RE-EVALUATE THIS EVENT IN ACCORDANCE WITH PROCEDURES.

    Description of Event or Problem · 1

    PER THE INFO PROVIDED TO CO BY HOSPITAL, THE DEVICE WAS REMOVED DUE TO A "TUBING FRACTURE". AS REPORTED TO US, THE ENTIRE DEVICE WAS REMOVED AND REPLACED WITH A 3-PIECE INFLATABLE PENILE PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARK II INFLATABLE PENILE PROSTHESIS Implant INFLATABLE PENILE PROSTHESIS FHW MENTOR UUROLOGY, INC. NA 012492

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention