BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALPHA I INFLATABLE PENILE PROSTHESIS

    MDR report key: 71818 · Received February 28, 1997

    Report

    Report Number
    2125050-1997-00104
    Event Type
    Injury
    Date Received
    February 28, 1997
    Date of Event
    February 3, 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 A REPRESENTATIVE PRESENT AT THE EXPLANT SURGERY, THE PHYSICIAN INDICATED THAT NOTHING WAS WRONG WITH THE DEVICE, FIBROUS TISSUE WAS FOUND AROUND SOME OF THE TUBING AND PUMP COMPONENT IMPEDING DEVICE FUNCTION. THE FIBROUS TISSUE WAS EXCISED AND THE DEVICE CYCLED FINE. THE CONNECTOR WAS RECEIVED AND EVALUATED BY THE MFR. NO FUNCTIONAL ABNORMALITIES WERE DETECTED WITH THIS COMPONENT. BASED ON THE RECEIVED INFO AND QUALITY ASSURANCE'S EVALUATION. QA CONCLUDES THE FOLLOWING. 1) NO ABNORMALITIES WERE NOTED WITH THIS COMPONENT. THUS, QA FOUND NO DEVICE RELATED REASON FOR THE REPORTED DIFFICULTY WITH DEFLATION. 2) HOWEVER, QA IS AWARE OF REASONS LISTED IN PRODUCT LITERATURE THAT CAN CAUSE OR CONTRIBUTED TO DIFFICULTY WITH DEFLATING A DEVICE. THEREFORE, QA WILL ACCEPT THAT AS THE REASON FOR SURGICAL INTERVENTION.

    Description of Event or Problem · 1

    THE DEVICE WAS REMOVED AS IT "WOULD NOT DEFLATE." A SINGLE CONNECTOR FROM THE ASSEMBLY KIT COMPONENT WAS REMOVED AND REPLACED; LEAVING THE PUMP/CYLINDER SET, CATALOG #99188, SERIAL #192172, RESERVOIR, CATALOG #9075K, SERIAL #195766 INPLACE FROM THE INITIAL IMPLANT SURGERY.

    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 R90186

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention