BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALPHA I INFLATABLE PENILE PROSTHESIS

    MDR report key: 71838 · Received February 28, 1997

    Report

    Report Number
    2125050-1997-00107
    Event Type
    Injury
    Date Received
    February 28, 1997
    Date of Event
    January 30, 1997
    Report Date
    February 28, 1997
    Manufacturer
    MENTOR UROLOGY, INC.
    Product Code
    FHW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE AVAILABLE INFO THIS INFLATABLE PENILE PROSTHESIS WAS IMPLANTED ON 1/25/96 AND REVISED ON 1/30/97 DUE TO "DEFLATION." IN THE RECEIVED INFO THE PHYSICIAN STATED THAT FLUID LOSS WAS NOTED AND THAT THE LOCATION OF THE FLUID LOSS WAS THE "JUNCTION OF (THE) CYLINDER TO THE TUBING." A PUMP AND TWO CYLINDERS WERE RETURNED FOR EVALUATION. EXAMINATION AND TESTING OF THE RETURNED COMPONENTS REVEALED A SEPARATION/LEAKAGE SITE IN CYLINDER #2'S STRAIN RELIEF AT THE APEX. THIS IS THE ONLY SITE OF LEAKAGE. EXAMINATION OF THE SURFACES OF THE SEPARATION REVEALED MARKINGS CHARACTERISTICS OF STRESS(S) INDUCED RENDING. ADDITIONALLY, OPPOSITE THE SEPARATION A CREASE MARK IS OBSERVED IN THE STRAIN RELIEF. BASED ON QA'S EXAMINATION AND THE PHYSICIAN'S OBSERVATIONS, QA CONCLUDED THAT WHILE IN-VIVO CYLINDER #2'S STRAIN RELIEF WAS PARTIALLY KINKED. QA FURTHER CONCLUDED THAT THIS POSITIONING. IN COMBINATION WITH DEVICE USAGE OVER TIME, CONTRIBUTED TO SUFFICIENT STRESS(S) TO REND THE STRAIN RELIEF AT THE NOTED SITE. THIS RENT WOULD ALLOW THE LOSS OF FLUID, LEADING THE REPORTED "DEFLATION," AND RENDING THE DEVICE INOPERABLE.

    Description of Event or Problem · 1

    THE DEVICE WAS REMOVED DUE TO "DEFLATION", SECONDARY TO A "TUBING BREAK CYLINDER." THE PUMP/CYLINDER SET AND SOME ASSEMBLY KIT COMPONENT ONLY WERE REMOVED AND REPLACED WITH ANOTHER CO'S PUMP/CYLINDER SET. THE RESERVOIR COMPONENT, CATALOG #9075K, SERIAL #191921, WAS LEFT IN PLACE FROM THE INITIAL IMPLANT SURGERY. 2/19/97 -UPON RECEIPT ADD'L INFO FROM THE PHYSICIAN/SURGEON, HE STATED, "THE DEVICE WAS REMOVED DUE TO FAILED TUBING AT CYLINDER JUNCTION."

    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 E90171/R90182

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention