BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFLATABLE PENILE PROSTHESIS

    MDR report key: 77203 · Received March 13, 1997

    Report

    Report Number
    2126328-1997-00938
    Event Type
    Injury
    Date Received
    March 13, 1997
    Date of Event
    February 11, 1997
    Report Date
    March 13, 1997
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FHW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED ON 3/24/97 INDICATES THE PATIENT WAS UNABLE TO INFLATE PENILE IMPLANT. REFER TO ACCESS NUMBER 1011009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFLATABLE PENILE PROSTHESIS Implant IPP FHW AMERICAN MEDICAL SYSTEMS, INC. 700 1273Q 002,1273Q 002,1273Q 002

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R