BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFLATABLE PENILE PROSTHESIS

    MDR report key: 101576 · Received June 27, 1997

    Report

    Report Number
    2126328-1997-02891
    Event Type
    Injury
    Date Received
    June 27, 1997
    Report Date
    June 27, 1997
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FHW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INFO RECEIVED INDICATES, "BETWEEN MARCH 1990 AND NOVEMBER 1994, 145 PTS 32 TO 79 YEARS OLD UNDERWENT INSERTION OF AMS700 ULTREX PENILE PROSTHESIS." "THE MALFUNCTION RATE ASSOCIATED WITH THE ULTREX CYLINDER WAS ONLY 3%. OF THESE 5 PTS 1 HAD AN ANEURYSMAL DILATATION WITH LEAK, 1 HAD A CYLINDER RUPTURE FROM EXCESSIVELY VIGOROUS INTERCOURSE, 1 HAD A CYLINDER RUPTURE OF UNK CAUSE, 1 REQUIRED REVISION FOR A MALPOSITIONED CYLINDER, AND 1 HAD A SMALL LEAK FROM 1 CYLINDER." "THE PROSTHESIS WAS REMOVED IN 1 PT WITH INFECTION." "OF 5 PTS WITH EROSION 1 HAD RECEIVED THE PROSTHESIS 2 YEARS BEFORE RETROPUBIC RADICAL PROSTATECTOMY...URETHRAL EROSION OCCURRED AT THE DISTAL RIGHT CORPOREAL BODY DUE TO AN INDWELLING FOLEY CATHETER PLACED... ONE PT HAD TUBING EROSION AT THE INFRAPUBIC INCISION SITE... 1 HAD EROSION AT THE URETHRAL MEATUS AFTER LEAVING THE IMPLANT PARTIALLY INFLATED AFTER INTERCOURSE." "SIX PTS HAD FLUID LEAKS (3 IN THE RESERVOIR), HAD A DISLODGED CONNECTION BETWEEN THE PUMP AND RESERVOIR, AND 2 HAD A LOOSE CONNECTOR AT AN UNSPECIFIED POINT." 1 PT REQUIRED A REVISION FOR A TUBING KINK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFLATABLE PENILE PROSTHESIS Implant IPP FHW AMERICAN MEDICAL SYSTEMS, INC. 700 NI,NI,NI,NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Hospitalization| R