BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GOS PEDIATRIC TRACHEOSTOMY TUBE

    MDR report key: 58314 · Received December 20, 1996

    Report

    Report Number
    8010092-1996-00074
    Event Type
    Injury
    Date Received
    December 20, 1996
    Report Date
    December 20, 1996
    Manufacturer
    RUSCH MFG (UK) LTD
    Product Code
    BTO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    INITIAL REASON FOR RETURN INCORRECT. IT IS NOW REPORTED THAT THE ANGLE OF THE PRODUCT IS EXCESSIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GOS PEDIATRIC TRACHEOSTOMY TUBE TRACHEOSTOMY TUBE BTO RUSCH MFG (UK) LTD NA 35U2/G315104

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other