BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GFS INFLATABLE PENILE PROSTHESIS

    MDR report key: 47855 · Received November 8, 1996

    Report

    Report Number
    2125050-1996-00592
    Event Type
    Injury
    Date Received
    November 8, 1996
    Date of Event
    September 18, 1996
    Report Date
    November 8, 1996
    Manufacturer
    MENTOR UROLOGY, INC.
    Product Code
    FHW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE AVAILABLE INFO THIS INFLATABLE PENILE PROSTHESIS WAS IMPLANTED ON 11/10/87 AND REMOVED ON 9/18/96 DUE TO A "MALFUNCTION" A PUMP, TWO CYLINDERS, A RESERVOIR, AND ASSOCIATED CONNECTORS AND REAR TIP EXTENDERS WERE RETURNED FOR EVALUATION. 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 SURROUND 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 TWO AREAS OF LEAKAGE. THE FIRST IS LOCATED NEAR THE DISTAL TUBE END OF OUTLET #1. SEVERAL SMALL SEPARATIONS ARE NOTED AT THIS SITE. THE SEPARATIONS ARE NOTED TO BE IN A LINEAR PATTERN AND EXMAINATION OF THE SURFACES OF THE SEPARATIONS REVEALED MARKINGS INDICATING CONTACT WITH SHARP, UNSHOD INSTRUMENTATION. THE SECOND AREA OF LEAKAGE IS NOTED NEAR THE DISTAL TUBE END OF THE INLET TUBING ON THE RESERVOIR. NUMEROUS SMALL SEPRATIONS ARE OBSERVED AT THIS SITE. THESE SEPARATIONS ARE ALSO IN A LINEAR PATTERN AND DISPLAY MARKINGS INDICATING CONTACT WITH SHARP, UNSHOD INSTRUMENTATION. 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. HOWEVER BECAUSE IMPLANT INFO WAS NOT PROVIDED, QA IS PRECLUDED FROM DETERMINING THE SEQUENCE OF EVENTS LEADING TO THE OBSERVED DAMAGE. NO OTHER FUNCTIONAL ABNORMALITIES WERE OBSERVED, HOWEVER ALL OF THE CONNECTOR/CLAMP ASSEMBLIES WERE RETURNED DISASSEMBLED, AND QA IS THEREFORE PRECLUDED FROM DETERMINING IF THEY CONTRIBUTED TO THE REPORTED "MALFUNCTION." BECAUSE THE AVAILABLE INFO DI DNOT PROVIDE ANY INDICATIONS AS TO WHAT FACTOR(S) MAY HAVE CONTRIBUTED TO THE REPORT OF A DEVICE "MALFUNCTION", QA IS PRECLUDED FROM DETERMINING THE CAUSE OF THE REPORTED EVENT. FREQUENCY AND SEVERITY OF REPORTS OF THIS NATURE ARE NO MORE FREQUENT OR SEVERE THAN WHAT IS STATED IN THE LABELING OR USUAL FOR SERVICE.

    Description of Event or Problem · 1

    PER THE INFO PROVIDED TO CO BY THE PHYSICIAN, THE DEVICE WAS REMOVED DUE TO A "MALFUNCTION." AS REPORTED TO CO, THE ENTIRE DEVICE WAS REMOVED AND REPLACED WITH A CO'S 3-PIECE INFLATABLE PENILE PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GFS INFLATABLE PENILE PROSTHESIS Implant INFLATABLE PENILE PROSTHESIS FHW MENTOR UROLOGY, INC. NA 012182-012182,012310,012314

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention