BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALPHA I INFLATABLE PENILE PROSTHESIS

    MDR report key: 103792 · Received July 9, 1997

    Report

    Report Number
    2125050-1997-00382
    Event Type
    Injury
    Date Received
    July 9, 1997
    Date of Event
    June 5, 1997
    Report Date
    July 9, 1997
    Manufacturer
    MENTOR UROLOGY, INC.
    Product Code
    FHW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE AVAILABLE INFORMATION THIS INFLATABLE PENILE PROSTHESIS WAS REVISED ON 6/5/97 BECAUSE "IT APPEARS TO HAVE NEEDLE PRICK IN CYLINDER AT BASE." NI IMPLANT INFORMATION WAS PROVIDED. A PUMP AND TWO CYLINDERS WERE RETURNED FOR EVALUAITON. REQUESTS HAVE BEEN MADE FOR ADDITIONAL INFORMATION SURROUNDING THE INCIDENT, HOWEVER, TO DATE THE REQUESTED INFORMATION HAS NOT BEEN RECEIVED. WITHOUT THE REQUESTED INFORMATION, QA IS PRECLUDED FROM COMMENTING ON THE EVENTS SURROUNDING THE INCIDENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED, QA WILL RE-EVALUATE THIS COMPLAINT IN ACCORDANCE WITH PROCEDURES. EXAMINATION AND TESTING OF THE RETURNED COMPONENTS REVEALED TWO SEPARATION/LEAKAGE SITES IN CYLINDER #2'S BLADDER NEAR THE BASE, CONFIRMING THE OBSERVATIONS AT EXPLANT. BECAUSE THESE COMPONENTS WERE RELEASED ACCORDING TI MANUFACTURING AND QUALITY CONTROL PROCEDURES, QA CONCLUDED THAT THE OBSERVED DAMAGE OCCURED SUBSEQUENT TO THE DEVICE PACKAGING BEING OPENED. BECAUSE THE LIMITED INFORMATION PROVIDED DOES NOT INDICATE ANY FACTORS THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT, QA IS PRECLUDED FROM DETERMINING OR COMMENTING ON THE SEQUENCE OF EVENTS RESULTING IN THE OBSERVED SEPARATIONS.

    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 "MALFUNCTION". AS REPORTED TO THE CO, THE PUMP/CYLINDER AND SOME ASSEMBLY KIT COMPONENT(S) ONLY WERE REMOVED AND REPLACED; LEAVING THE RESERVOIR IN PLACE FROM THE INITIAL IMPLANT.

    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 E90104

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention