BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYNAFLEX PENILE PROSTHESIS

    MDR report key: 88322 · Received May 2, 1997

    Report

    Report Number
    2126328-1997-01898
    Event Type
    Injury
    Date Received
    May 2, 1997
    Date of Event
    April 3, 1997
    Report Date
    May 2, 1997
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FHW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CYLINDERS HAD A WEAR LEAK.

    Description of Event or Problem · 1

    INFORMATION RECEIVED ON 5/14/97 INDICATES ADDITIONAL REASON AS A VERY, VERY SMALL CYLINDER LEAK AT SITE OF INPUT TUBE. REFERENCE UF/DIST #2030167-1997-0009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DYNAFLEX PENILE PROSTHESIS Implant DPP FHW AMERICAN MEDICAL SYSTEMS, INC. DYNAFLEX C4922 030,0618Q 014

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R