BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFLATABLE PENILE PROSTHESIS

    MDR report key: 105298 · Received July 11, 1997

    Report

    Report Number
    2126328-1997-03227
    Event Type
    Injury
    Date Received
    July 11, 1997
    Date of Event
    June 4, 1998
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FHW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AN IPP DEVICE WAS IMPLANETED ON 05/29/1984. A CONNECTOR WAS REVISED ON 09/23/1991. THE PUMP AND CYLINDERS WERE REMOVED FROM THE PT AND REPLACED, DATE AND REASON NOT INDICATED. AMS HAS REQUESTED ADDITIONAL INFORMATION. INFORMATION RECEIVED ON 07/16/1997 INDICATES THE SURGERY WAS PERFORMED ON 06/04/1997 DUE TO WOULD NOT INFLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFLATABLE PENILE PROSTHESIS Implant IPP FHW AMERICAN MEDICAL SYSTEMS, INC. 700 3090B,3090B,5010C

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R