BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMERICAN MEDICAL SYSTEMS

    MDR report key: 110869 · Received July 10, 1997

    Report

    Report Number
    110869
    Event Type
    Injury
    Date Received
    July 10, 1997
    Date of Event
    June 11, 1997
    Report Date
    July 10, 1997
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, PFIZER HOSP PRODUCTS GROUP
    Product Code
    FHW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MALFUNCTIONING PENILE PROTHESIS REMOVED IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMERICAN MEDICAL SYSTEMS Implant ULTREX PLUS FHW AMERICAN MEDICAL SYSTEMS, PFIZER HOSP PRODUCTS GROUP UNK *

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization