BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IPP INFLATABLE PENILE PROSTHESIS

    MDR report key: 116167 · Received August 29, 1997

    Report

    Report Number
    2125050-1997-00468
    Event Type
    Injury
    Date Received
    August 29, 1997
    Date of Event
    July 21, 1997
    Report Date
    July 30, 1997
    Manufacturer
    MENTOR UROLOGY, INC.
    Product Code
    FHW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFO THIS INFLATABLE PENILE PROSTHESIS WAS IMPLANTED ON 9/20/1995 AND REMOVED REPLACED ON 7/21/1997 DUE TO "HYDROLIC DYSFUNCTION" AND "MALFUNCTION LEAK IN SYSTEM." ADDITIONALLY, A "L CORPORAL CYLINDER LEAK FROM TUBING EROSION" WAS NOTED, AND ON PROVIDED DIAGRAM TUBING BETWEEN PUMP AND CYLINDER IS CIRCLED WITH "L TUBING EROSION" WRITTEN NEXT TO IT. PUMP, TWO CYLINDRS, AND RESERVOIR WERE RETURNED FOR EVAL. EXAMINATION AND TESTING OF RETURNED COMPONENTS REVEALED NO FUNCTIONAL ABNORMALITIES. BECAUSE INFO RECEIVED DOES NOT INDICATE WHAT FACTORS(S) MAY HAVE CONTRIBUTED TO OBSERVED "LEAK" AND BECAUSE NO FUNCTIONAL ABNORMALITIES WERE DETECTED, QA IS PRECLUDED FROM DETERMINING CAUSE OF REPORTED EVENT. SERIALIZED CYLINDER AND RESERVOIR COMPONENTS WERE RECEIVED DETACHED FROM PUMP. EXAMINATION OF SURFACES OF DISTAL TUBE ENDS REVEALED MARKINGS INDICATING CONTACT WITH SHARP INSTRUMENTATION ACROSS THE ENTIRE CROSS SECTIONAL SURFACE. BECAUSE THESE COMPONENTS WERE RELEASED ACCORDING TO MFG AND QUALITY CONTROL PROCEDURES, QA CONCLUDED THAT OBSERVED DAMAGE OCCURRED SUBSEQUENT TO DEVICE PACKAGING BEING OPENED. IN ADDITION, BECAUSE EXPECTED USE OF THIS DEVICE COMBINED WITH OBSERVED DAMAGE WOULD HAVE RESULTED IN AN EARLIER DETECTED/SPONTANEOUS FLUID LOSS, QA CONCLUDED AHT THE DAMAGE MOST LIKELY OCCURRED DURING OR SUBSEQUENT TO EXPLANT.

    Description of Event or Problem · 1

    PER THE INFO PROVIDED TO CO BY THE PHYSICIAN'S OFFICE, THE DEVICE WAS REMOVED DUE TO A "LEAK IN (THE) SYSTEM." AS REPORTED TO CO, THE ENTIRE DEVICE WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IPP INFLATABLE PENILE PROSTHESIS Implant INFLATABLE PENILE PROSTHESIS FHW MENTOR UROLOGY, INC. NA 012346-012346/E90171/E90166

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention