BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFLATABLE PENILE PROSTHESIS

    MDR report key: 51007 · Received November 21, 1996

    Report

    Report Number
    2126328-1996-05417
    Event Type
    Injury
    Date Received
    November 21, 1996
    Date of Event
    June 13, 1996
    Report Date
    November 21, 1996
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FHW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE ENTIRE DEVICE WAS REMOVED FROM THE PT DUE TO INFECTION. ADD'L LOT/SER NO: BK924 006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFLATABLE PENILE PROSTHESIS Implant IPP FHW AMERICAN MEDICAL SYSTEMS, INC. 700 1580Q 009,1580Q 009,BG883 006

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R