BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFLATABLE PENILE PROSTHESIS

    MDR report key: 120938 · Received September 19, 1997

    Report

    Report Number
    2125050-1997-00503
    Event Type
    Injury
    Date Received
    September 19, 1997
    Date of Event
    July 25, 1997
    Report Date
    August 21, 1997
    Manufacturer
    MENTOR UROLOGY, INC.
    Product Code
    FHW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE AVAILABLE INFO THIS INFLATABLE PENILE PROSTHESIS WAS REVISED ON 7/25/1997 DUE TO A "MALFUNCTION." NO IMPLANT INFO WAS PROVIDED. TWO CYLINDERS WERE RETURNED FOR EVALUATION, HOWEVER NO INFO REFERENCING THE TYPE OF DEVICE THE CYLINDERS WERE REMOVED FROM WAS RECEIVED. REQUESTS HAVE BEEN MADE FOR ADDITIONAL INFO SURROUNDING THE INCIDENT, HOWEVER, TO DATE THE REQUESTED INFO HAS NOT BEEN RECEIVED. WITHOUT THE REQUESTED INFO, QA IS PRECLUDED FROM COMMENTING ON THE EVENTS SURROUNDING THE INCIDENT. SHOULD ADDITIONAL INFO BE RECEIVED, QA WILL RE-EVALUATE THIS COMPLAINT IN ACCORDANCE WITH PROCEDURES. EXAMINATION AND TESTING OF THE RETURNED COMPONENTS REVEALED AN ANEURYSM IN CYLINDER #1'S BLADDER NEAR THE BASE. NO OTHER FUNCTIONAL ABNORMALITIES WERE NOTED. BECAUSE THESE COMPONENTS WERE RELEASED ACCORDING TO MFG AND QUALITY CONTROL PROCEDURES, QA CONCLUDED THAT THE OBSERVED DAMAGE OCCURRED SUBSEQUENT TO THE DEVICE PACKAGING BEING OPENED. BECAUSE NO INFO WAS PROVIDED AS TO WHAT FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED "MALFUNCTION" OR THE OBSERVED ANEURYSM, QA IS PRECLUDED FROM DETERMINING THE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    PER THE INFO PROVIDED TO CO BY THE PHYSICIAN'S OFFICE, THE DEVICE WAS REMOVED DUE TO A "MALFUNCTION." AS REPORTED TO CO, ONLY THE CYLINDERS WERE REMOVED AND REPLACED, LEAVING THE REST OF THE DEVICE IN PLACE.

    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 NA Required Intervention