BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARK II INFLATABLE PENILE PROSTHESIS

    MDR report key: 113008 · Received August 15, 1997

    Report

    Report Number
    2125050-1997-00450
    Event Type
    Injury
    Date Received
    August 15, 1997
    Date of Event
    March 11, 1997
    Report Date
    July 21, 1997
    Manufacturer
    MENTOR UROLOGY, INC.
    Product Code
    FHW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE AVAILABLE INFO THIS INFLATABLE PENILE PROSTHESIS WAS IMPLANTED ON 5/10/1990 AND REMOVED ON 3/11/1997 DUE TO "DEFLATION." A RESIPUMP AND TWO CYLINDERS WERE RETURNED FOR EVALUATION. EXAMINATION AND TESTING OF THE RETURNED COMPONENTS REVEALED A COMPLETE SEPARATION OF THE BOTH OUTLETS. THE OBVIOUS SEPARATION OF COMPONENTS AT THESE SITES WOULD ALLOW LEAKAGE. EXAMINATION OF THE SURFACES, OF BOTH SIDES OF THE SEPARATION OF THER SERIALIZED OUTLET, REVEALED MARKINGS CHARACTERISTIC OF STRESS(S) INCLUDING RENDING. FURTHER EXAMINATION REVEALED, ON BOTH SIDES OF THE SEPARATION, CONFINED AREAS OF ABRASION ADJACENT TO THE SEPARATION EDGES. ADDITIONALLY, EIGHT CREASE MARKS ARE NOTED IN THE TUBING ON THE CYLINDER SIDE. EXAMINATION OF THE SURFACES OF THE SEPARATION OF THE NON-STERILIZED OUTLET REVEALED MARKINGS INDICATING CONTACT WITH SHARP INSTUMENTATION ACROSS THE ENTIRE CORSS SECTIONAL SURFACE. BASED ON QA'S EXAMINATION AND THE LIMITED INFO RECEIVED, QA CONCLUDED THAT WHILE IN-VIVO THE SERIALIZED OUTLET'S TUBING WAS PARTIALLY KINKED AND ABRADING AGAINST ITSELF. QA FURTHER CONCLUDED THAT THIS POSITIONING, IN COMBINATION WITH DEVICE USAGE OVER TIME, CONTRIBUTED TO SUFFICIENT STRESS(S) TO REND THE TUBING AT THIS SITE. THIS RENT WOULD ALLOW THE LOSS OF FLUID AND SUBSEQUENT "DEFLATION." BECAUSE THESE COMPONENTS WERE RELEASED ACCORDING TO MFG AND QUALITY CONTROL PROCEDURES, QA CONCLUDED THAT THE OBSERVED DAMAGE TO THE NON-STERILIZED OUTLET, OCCURRED SUBSEQUENT TO THE DEVICE PACKAGING BEING OPENED. IN ADDITION, BECAUSE THE EXPECTED USE OF THIS DEVICE COMBINED WITH THE OBSERVED DAMAGE WOULD HAVE RESULTED IN AN EARLIER DETECTED FLUID LOSS, QA CONCLUDED THAT THE DAMAGE MOST LIKELY OCCURRED AT OR SUBSEQUENT TO EXPLANT.

    Description of Event or Problem · 1

    PER THE INFO PROVIDED TO CO BY THE PHYSICIAN'S OFFICE, THROUGH INTERNATIONAL REP, THE DEVICE WAS REMOVED DUE TO "DEFLATION". AS REPORTED TO CO, THE ENTIRE DEVICE WAS REMOVED.

    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 012490

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention