BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFLATABLE PENILE PROSTHESIS

    MDR report key: 48695 · Received November 12, 1996

    Report

    Report Number
    2125050-1996-00581
    Event Type
    Injury
    Date Received
    November 12, 1996
    Date of Event
    October 7, 1996
    Report Date
    November 12, 1996
    Manufacturer
    MENTOR UROLOGY, INC.
    Product Code
    FHW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFO THIS INFLATABLE PENILE PROSTHESIS WAS REMOVED ON 10/4/96 DUE TO "LEAKAGE OF PUMP." ADD'L INFO STATED THAT LEAKAGE WAS NOTED IN RESERVOIR. A RESIPUMP AND TWO CYLINDERS WERE RETURNED FOR EVAL. NO IMPLANT INFO WAS PROVIDED. REQUESTS HAVE BEEN MADE FOR ADD'L INFO SURROUNDING INCIDENT; HOWEVER, TO DATE REQUESTED INFO HAD NOT BEEN RECEIVED. WITHOUT REQUESTED INFO, QA IS PRECLUDED FROM COMMENTING ON EVENTS SURROUNDING INCIDENT. SHOULD ADD'L INFO BE RECEIVED, QA WILL RE-EVALUATE THIS COMPLAINT IN ACCORDANCE WITH PROCEDURES. EXAMINATION AND TESTING OF RETURNED COMPONENTS REVEALED A SEPARATION/LEAKAGE SITE IN RESIPUMP BLADDER. THIS IS ONLY SITE OF LEAKAGE. EXAMINATION OF SURFACES OF SEPARATION REVEALED MARKINGS INDICATING CONTACT WITH SHARP INSTRUMENTATION. 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 QA'S EXAMINATION AND LIMITED INFO PROVIDED, QA CONCLUDED THAT OBSERVED BLADDER SEPARATION WAS ONLY SITE THAT WOULD HAVE ALLOWED "LEAKAGE OF PUMP." HOWEVER, BECAUSE NO IMPLANT INFO WAS PROVIDED, QA IS PRECLUDED FROM DETERMINING SEQUENCE OF EVENT RESULTING IN OBSERVED SEPARATION.

    Description of Event or Problem · 1

    THE DEVICE WAS REMOVED DUE TO "LEAKAGE FROM THE PUMP". AS REPORTED TO CO, THE ENTIRE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER 2-PIECE INFLATABLE PENILE PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFLATABLE PENILE PROSTHESIS Implant INFLATABLE PENILE PROSTHESIS FHW MENTOR UROLOGY, INC. NA E90106

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention