BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 1000436 · Received February 21, 2008

    Report

    Report Number
    2936999-2008-00078
    Event Type
    Injury
    Date Received
    February 21, 2008
    Date of Event
    January 1, 2007
    Report Date
    January 23, 2008
    Manufacturer
    HENEQUEN
    Product Code
    BTO
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE COMPANY RECEIVED INFO THAT SUGGESTED THAT THE PRODUCT HAD A RING SHAPED CIRCLE AROUND THE CUFF THAT WAS STIFFER THAN THE REST OF THE CUFF AND DID NOT APPEAR TO DEFLATE PROPERLY. THE CUSTOMER REPORTED THAT THIS WAS DISCOVERED AFTER THE PT WAS EXTUBATED AND REQUIRED A TREATMENT OF RACEMIC EPINEPHRINE DUE TO STRIDOR AND AIRWAY EDEMA. POST TREATMENT, THE PT WAS BREATHING NORMALLY AND NO FURTHER TREATMENT WAS NEEDED. THE CUSTOMER DISCARDED THE SAMPLE AND DOES NOT HAVE RECORD OF THE LOT NUMBER OF THE SAMPLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Required Intervention