BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 1001079 · Received February 22, 2008

    Report

    Report Number
    2936999-2008-00088
    Event Type
    Injury
    Date Received
    February 22, 2008
    Date of Event
    January 1, 2008
    Report Date
    January 25, 2008
    Manufacturer
    HENEQUEN
    Product Code
    BTR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE COMPANY RECEIVED INFO THAT SUGGESTED THAT THE CUFF WOULD NOT STAY INFLATED WHILE IN PT USE. THE CUSTOMER REPORTED THAT THE PT WAS RE-INTUBATED AND NO HARM WAS REPORTED. THE CUSTOMER DISCARDED THE SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALLINCKRODT ENDOTRACHEAL TUBE BTR HENEQUEN 124175 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Required Intervention