BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAFETY CLEAR PLUS MAGILL/CUFFED

    MDR report key: 185316 · Received September 1, 1998

    Report

    Report Number
    8040412-1998-00053
    Event Type
    Injury
    Date Received
    September 1, 1998
    Date of Event
    August 13, 1998
    Report Date
    September 1, 1998
    Manufacturer
    RUSCH MFG. SDN. BHD.
    Product Code
    BTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FIRST TWO OF THREE DEVICES HAD BALLOON LEAKAGE. THE THIRD DEVICE PERFORMED AS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFETY CLEAR PLUS MAGILL/CUFFED ENDOTRACHEAL TUBE BTR RUSCH MFG. SDN. BHD. NA 97GE3

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention