BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFLATABLE PENILE PROSTHESIS

    MDR report key: 90922 · Received May 9, 1997

    Report

    Report Number
    2126328-1997-02069
    Event Type
    Injury
    Date Received
    May 9, 1997
    Date of Event
    July 9, 1997
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FHW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PUMP PERFORMED WITHIN SPECIFICATION. RESERVOIR PERFORMED WITHIN SPECIFICATIONS. CYLINDER PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD TORN FABRIC AND BULGING.

    Description of Event or Problem · 1

    ON 6/14/1990 AN IPP DEVICE WAS IMPLANTED. ON 4/11/1997 THE DR REPORTED "DEVICE IS NOT INFLATING." INFO RECEIVED ON 12/15/1997 INDICATED THE ENTIRE DEVICE WAS REMOVED FROM THE PT ON 7/9/1997.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFLATABLE PENILE PROSTHESIS Implant IPP FHW AMERICAN MEDICAL SYSTEMS, INC. 700 2005L 012,2005L 012 (MORE)

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R| S