BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFLATABLE PENILE PROSTHESIS

    MDR report key: 84460 · Received April 10, 1997

    Report

    Report Number
    2125050-1997-00185
    Event Type
    Injury
    Date Received
    April 10, 1997
    Date of Event
    March 4, 1997
    Report Date
    April 10, 1997
    Manufacturer
    MENTOR UROLOGY, INC.
    Product Code
    FHW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE AVAILABLE INFO, THIS DEVICE WAS IMPLANTED ON 11/4/91 AND REMOVED ON 3/4/97. THIS EVENT WAS REPORTED AS A "MALFUNCTION." ADD'L INFO WAS REQUESTED, BUT WAS NOT RECEIVED. THEREFORE QA IS PRECLUDED FROM COMMENTING ON THE CIRCUMSTANCES SURROUNDING THIS EVENT. QA WAS UNSUCCESSFUL IN SECURING THE DEVICE FOR EVALUATION. WITHOUT THE BENEFIT OF ANALYZING THE EXPLANTED DEVICE, QA IS PRECLUDED FROM CONFORMING THE MALFUNCTION AND PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE. SHOULD THE EXPLANTED BECOME AVAILABLE, QA WILL REOPEN THIS FILE AND PROCEED ACCORDING TO PROCEDURES.

    Description of Event or Problem · 1

    THE DEVICE WAS REMOVED DUE TO A "MALFUNCTION". AS REPORTED TO CO, PUMP/CYLINDER AND ASSEMBLY KIT COMPONENTS ONLY WERE REMOVED AND REPLACED; LEAVING IN PLACE THE RESERVOIR FROM THE INITIAL IMPLANT SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFLATABLE PENILE PROSTHESIS Implant INFLATABLE PENILE PROSTHESIS FHW MENTOR UROLOGY, INC. NA 012518/R90044

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention