BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALPHA I INFLATABLE PENILE PROSTHESIS

    MDR report key: 87436 · Received April 30, 1997

    Report

    Report Number
    2125050-1997-00214
    Event Type
    Injury
    Date Received
    April 30, 1997
    Date of Event
    March 21, 1997
    Report Date
    April 30, 1997
    Manufacturer
    MENTOR UROLOGY, INC.
    Product Code
    FHW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS REMOVED DUE TO "A TUBING FRACTURE AT THE PUMP STRAIN RELIEF". AS REPORTED TO CO, THE PUMP AND SOME ASSEMBLY KIT COMPONENT(S) ONLY WERE REMOVED; LEAVING INPLACE THE CYLINDER(S), CATALOG #9920W, SERIAL #139220 AND RESERVOIR, CATALOG #9100K, SERIAL #152481. 4/23/97 - UPON RECEIPT OF THE PHYSICIAN/SURGEONS OPERATIVE REPORT, HE STATED,..."POSTOPERATIVE DIAGNOSIS: MALFUNCTION OF PENILE PROSTHESIS. OPERATIVE PROCEDURE: REVISION OF PROSTHESIS WITH REPLACEMENT OF PUMP. SUMMARY,..."THE PUMP AND ALL THE TUBING CONNECTORS WERE TRACED OUT AND THE PROBLEM DIAGNOSED. THERE WAS A FRACTURE OF THE TUBING WHERE IT EXITED THE PUMP PLATFORM. BOTH TUBINGS OF THE CYLINDER VARIETY WERE FRACTURED ADN LEAKING. THE RESERVOIR CONNECTOR WAS CUT DOWN UPON AND THE PUMP WAS REMOVED. A NEW PUMP WAS THEN CONNECTED TO ALL THREE CONNECTIONS WITH THREE CONNECTORS".

    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 E90074/R90073

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention