BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRACOE SILCOSOFT

    MDR report key: 10756919 · Received October 29, 2020

    Report

    Report Number
    10756919
    Event Type
    Malfunction
    Date Received
    October 29, 2020
    Date of Event
    September 26, 2020
    Report Date
    September 28, 2020
    Manufacturer
    TRACOE MEDICAL GMBH
    Product Code
    JOH
    UDI-DI
    04035324031399
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TRACHEOSTOMY TUBE WITH ONE SIZE PRINTED ON WING AND A DIFFERENT SIZE PRINTED ON BALLOON.

    Description of Event or Problem · 1

    TRACHEOSTOMY TUBE WITH ONE SIZE PRINTED ON WING AND A DIFFERENT SIZE PRINTED ON BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1219885 TRACOE SILCOSOFT TUBE TRACHEOSTOMY AND TUBE CUFF JOH TRACOE MEDICAL GMBH REF 373-4.0-C45 1000166737 04035324031399

    Patients

    Seq Age Sex Outcome Treatment
    1