BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALPHA I INFLATABLE PENILE PROSTHESIS

    MDR report key: 126630 · Received October 17, 1997

    Report

    Report Number
    2125050-1997-00538
    Event Type
    Injury
    Date Received
    October 17, 1997
    Date of Event
    August 25, 1997
    Report Date
    September 18, 1997
    Manufacturer
    MENTOR UROLOGY, INC.
    Product Code
    FHW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFO THIS INFLATABLE PENILE PROSTHESIS WAS IMPLANTED ON 6/16/1994, REVISED ON 1/20/1995 DUE TO AN "ANEURYSM OF THE RIGHT CYLINDER" AND AN "ANEURYSM OF THE RIGHT COPORA." THIS EVENT HAS BEEN ADDRESSED BY ANOTHER FILE. ON 8/25/1997 THE DEVICE WAS REVISED AGAIN DUE TO RUPTURED CYLINDER. THE PHYSICIAN STATED THAT A "BULGE IS NOTED IN THE RIGHT CYLINDER" AND THAT THIS WAS A "HYDRAULIC DEFORMITY DUE TO OVER INFLATION OF THE DEVICE." THE PHYSICIAN FURTHER STATED THAT HE HAD "CAUTIONED THE PT NOT TO CONTINUE TO OVER-INFLATE THE DEVICE." AT THE TIME OF SURGERY THE PHYSICIAN NOTED THAT THE RIGHT CYLINDER WAS "LEAKING." A PUMP AND TWO CYLINDERS WERE RETURNED FOR EVALUATION. EXAMINATION AND TESTING OF THE RETURNED COMPONENTS REVEALED AN ANEURYSM IN THE BLADDER OF CYLINDER #1 NEAR THE BASE. ACROSS THE ANEURYZED PORTION OF THE BLADDER A SEPARATION IS NOTED, CONFIRMING THE NOTED BULGING AND LOSS OF FLUID. EXAMINATION OF THE SURFACES OF THE SEPARATION REVEALED NO MARKINGS INDICATING CONTACT WITH INSTRUMENTATION. WITHIN THE SEPARATION A SMALL AREA WHERE MATERIAL IS MISSING IS OBSERVED. BECAUSE THESE COMPONENTS WERE RELEASED ACCORDING TO MFG AND QUALITY CONTROL PROCEDURES, QA CONCLUDED THAT OBSERVED DAMAGE OCCURRED SUBSEQUENT TO DEVICE PACKAGING BEING OPENED. BASED ON QA'S EXAMINATION AND THE LIMITED INFO PROVIDED, QA CONCLUDED THAT THE REPEATED OVER INFLATION OF DEVICE WHILE IN-VIVO MOST LIKELY CONTRIBUTED TO NOTED ANEURYSM AND SUBSEQUENT SEPARATION. QA FURTHER CONCLUDED THAT THE PRESENCE OF A PREVIOUSLY ANEURYZED CORPORA MAY HAVE CONTRIBUTED TO THIS EVENT AS THIS DEVICE IS CAPABLE OF GENERATING PRESSURE SUFFICIENT TO ANEURYZE AN UNRESTRICTED BLADDER. QA IS PRECLUDED FROM DETERMINING THE CAUSE OF THE NOTED AREA WITHIN THE SEPARATION WITH MATERIAL MISSING AS THE APPEARANCE OF THE SURFACES OF THIS AREA ARE NOT CONSISTENT WITH PREVIOUSLY OBSERVED INSTRUMENT DAMAGE OR NORMAL DEVICE WEAR. QA IS FURTHER PRECLUDED FROM DETERMINING WHEN THIS DAMAGE OCCURRED AND THEREFORE CANNOT DETERMINE IF THIS AREA CONTRIBUTED TO THE NOTED SEPARATION.

    Description of Event or Problem · 1

    PER THE INFO PROVIDED TO THE CO BY THE PHYSICIAN'S OFFICE, THE DEVICE WAS REMOVED DUE TO A "RUPTURED CYLINDER." AS REPORTED TO THE CO, THE RESERVOIR WAS LEFT IN PLACE, WHILE THE REST OF THE DEVICE WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALPHA I INFLATABLE PENILE PROSTHESIS Implant INFLATABLE PENILE PROSTHESIS FHW MENTOR UROLOGY, INC. NA E90128/E90052/R90114

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention