BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 808492 · Received January 23, 2007

    Report

    Report Number
    2936999-2007-00032
    Event Type
    Injury
    Date Received
    January 23, 2007
    Date of Event
    January 16, 2007
    Report Date
    January 23, 2007
    Manufacturer
    JUAREZ HENEQUEN
    Product Code
    BSR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON 01/23/2007, NELLCOR RECEIVED A REPORT WHERE IT WAS CLAIMED THAT THE CUFF ON THE REPORTED DEVICE DEVELOPED A LEAKING DURING PATIENT USE. THE TUBE WAS REPLACED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALLINCKRODT HI-LO TRACH TUBE 8.0MM BX/10 BSR JUAREZ HENEQUEN HI-LO TRACH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR