BEUDAMED
    FDA Adverse Event Other Summary report: N

    PEDIATRIC TRACHEOSTOMY TUBE

    MDR report key: 125007 · Received October 8, 1997

    Report

    Report Number
    1220850-1997-00001
    Event Type
    Other
    Date Received
    October 8, 1997
    Date of Event
    September 9, 1997
    Manufacturer
    E. BENSON HOOD LAB, INC.
    Product Code
    BTO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    THE INITIAL REPORT TO HOOD LABORATORIES THAT A PEDIATRIC TRACHEOSTOMY TUBE FRACTURED IN A PT CAME TO CO VIA A PHONE CALL FROM THE PT'S MOTHER. SHE STATED THAT THE TRACHEOSTOMY TUBE, WHICH HAS BEEN IN USE FOR APPROX. ONE YEAR, FRACTURED AND REQUIRED SURGICAL INTERVENTION. THIS IS ALL THE INFO CO HAS AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEDIATRIC TRACHEOSTOMY TUBE TRACHEOSTOMY TUBE BTO E. BENSON HOOD LAB, INC. 20045 42025

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention