BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INMED

    MDR report key: 68324 · Received February 6, 1997

    Report

    Report Number
    68324
    Event Type
    Injury
    Date Received
    February 6, 1997
    Date of Event
    January 23, 1997
    Report Date
    February 5, 1997
    Manufacturer
    INMED CORP.
    Product Code
    KOE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FILIFORM AND FOLLOWER WERE BEING USED TO DILATE THE PT'S URETHRA. THE FILIFORM WAS IN THE PT WHEN THE SCREW END OF THE FILIFORM BROKE OFF, LEAVING THE SCREW END ATTACHED TO THE FOLLOWER AND THE FILIFORM IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INMED 3 FR FILIFORM CATHETER KOE INMED CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention