BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFLATABLE PENILE PROSTHESIS

    MDR report key: 117752 · Received September 4, 1997

    Report

    Report Number
    2126328-1997-03902
    Event Type
    Injury
    Date Received
    September 4, 1997
    Date of Event
    August 4, 1997
    Report Date
    September 4, 1997
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FHW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PUMP AND CYLINDERS WERE REMOVED FROM THE PATIENT AND REPLACED DUE TO FIBROSIS AROUND RESERVOIR, ANEURYSM-LEFT CYLINDER, AND PEYRONIE'S DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFLATABLE PENILE PROSTHESIS Implant IPP FHW AMERICAN MEDICAL SYSTEMS, INC. 700 9561K 015,9561K 015,AV372 006

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R