BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGT NASAL CUFFED

    MDR report key: 481690 · Received August 28, 2003

    Report

    Report Number
    8040412-2003-00103
    Event Type
    Malfunction
    Date Received
    August 28, 2003
    Report Date
    August 27, 2003
    Manufacturer
    RUSCH SDN. BHD.
    Product Code
    BTK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS TUBE IS TOO FLIMSY TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AGT NASAL CUFFED ANESTHESIA BTK RUSCH SDN. BHD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN