BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALPHA I INFLATABLE PENILE PROSTHEIS

    MDR report key: 42351 · Received October 11, 1996

    Report

    Report Number
    2125050-1996-00516
    Event Type
    Injury
    Date Received
    October 11, 1996
    Date of Event
    September 9, 1996
    Report Date
    October 10, 1996
    Manufacturer
    MENTOR UROLOGY, INC.
    Product Code
    FHW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE AVAILABLE INFO, THIS PENILE PROSTHESIS WAS IMPLANTED ON 3/23/1994. IT WAS EXPLANTED ON 9/9/1996, REPORTEDLY DUE TO A "CRACK IN BETWEEN THE PUMP AND CYLINDER." IN THE RECEIVED QUESTIONNAIRE, THE PHYSICIAN INDICATED THE FOLLOWING: THERE WAS A SPECIFIC LEAKAGE SITE OBSERVED "NEAR PUMP ON TUBING TO A CYLINDER," THE TUBING WAS NEITHER KINKED OR TWISTED WHEN HE OPENED THE POCKET, WHEN IMPLANTED NO EXESSIVE NOR INADEQUATE TUBING LENGHTS WERE OBSERVED, NOTHING WAS NOTED IN THE POSITIONING THAT MAY HAVE CAUSED STRESS(ES) TO THE DEVICE, AND THE DEVICE DID NOT CONTACT ANY UNSHOD, SHARP INSTRUMENTATION DURING OR SUBSEQUENT TO REMOVAL. THE TWO CYLINDERS AND THE PUMP WERE RECEIVED AND EVALUATED BY THE MFR. THE COMPONENTS PASSED ALL FUNCTIONAL TESTS. A MICROSCOPIC EXAMINATION OF THE TUBING ENDS SHOWED UNIFROM STRIATIONS ON THE SURFACES, INDICATING CONTACT WITH SHARP INSTURMENTATION, E.G. SCALPEL, SCISSORS. BASED ON THE DURATION THE DEVICE WAS IMPLANTED, QUALITY ASSURANCE CONCLUDES THAT THE CONTACT WITH SHARP INSTRUMENTATION OCCURRED DURING OR SUBSEQUENT OT EXPLANT SURGERY, AND THIS, IS NOT RELATED TO THE COMPLAINT. QA CAN NOT CONFIRM THE REPORTED CRACK IN BETWEEN THE PUMP AND CYLINDER.

    Description of Event or Problem · 1

    PER THE INFO PROVIDED TO CO BY HOSPITAL, THE DEVICE WAS REMOVED DUE TO A "CRACK IN THE TUBING FROM THE PUMP TO THE CYLINDER". AS REPORTED TO CO, THE CYLINDER(S), PUMP AND ASSEMBLY KIT COMPONENT(S) ONLY WERE REMOVED AND REPLACED WITH ANOTHER PUMP AND CYLINDER ASSEMBLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALPHA I INFLATABLE PENILE PROSTHEIS Implant INFLATABLE PENILE PROSTHESIS FHW MENTOR UROLOGY, INC. NA E90121/R90114

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention