BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRACHEOSTOMY TUBE NECKBAND

    MDR report key: 3397101 · Received October 7, 2013

    Report

    Report Number
    MW5032175
    Event Type
    Malfunction
    Date Received
    October 7, 2013
    Date of Event
    October 1, 2013
    Report Date
    October 7, 2013
    Manufacturer
    MEDLINE
    Product Code
    CBH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    HOME HEALTH LPN NURSE CALLED IN TO REPORT ABOUT A DEFECTIVE TRACHEOSTOMY TUBE NECKBAND BEEN USED ON HER (B)(6) MENTALLY RETARDED PT. THE NECKBAND CAN EASILY BE DISLODGED WHICH CAN CAUSE A LIFE THREATENING ISSUE TO HER PT. NURSE HAVE CALLED THE SUPPLY COMPANY TO REPORT THE ISSUE WITH THE NECKBAND BUT THEY STILL SEND THE SAME DEFECTIVE NECKBAND TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507051 TRACHEOSTOMY TUBE NECKBAND TECH HOLDER CBH MEDLINE 36277182

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Other