BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRACHEAL TUBE

    MDR report key: 12351216 · Received August 20, 2021

    Report

    Report Number
    3012307300-2021-08702
    Event Type
    Malfunction
    Date Received
    August 20, 2021
    Date of Event
    July 22, 2021
    Report Date
    September 1, 2021
    Product Code
    LNZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: PRODUCT CODE AND COMMON DEVICE NAME ADDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PLASTIC LOCK PULLED AWAY FROM THE ADHESIVE BACKING FROM PARALYZED PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1249090 TRACHEAL TUBE LNZ 3942834

    Patients

    Seq Age Sex Outcome Treatment
    1