BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOFLO NEO

    MDR report key: 2694136 · Received August 6, 2012

    Report

    Report Number
    2247040-2012-00001
    Event Type
    Malfunction
    Date Received
    August 6, 2012
    Date of Event
    June 28, 2012
    Report Date
    August 6, 2012
    Manufacturer
    ARC MEDICAL, INC.
    Product Code
    BYD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT 6215 WAS SHIPPED IN A BOX THAT WAS LABELED FOR PRODUCT 6220. PRODUCT 6220 WAS CORRECT FOR THE PT. PRODUCT 6215 WAS NOT USED ON THE PT. THE MISLABELING WAS REPORTED TO ARC MEDICAL, INC. ON (B)(4) 2012, AND THE CORRECT PRODUCT WAS SHIPPED OVERNIGHT TO THE USER. THE INCORRECTLY LABELED PRODUCT WAS RETURNED TO ARC MEDICAL, INC. THE INDIVIDUALS INVOLVED IN THE INCORRECT PRODUCT BEING SHIPPED WERE INFORMED OF THE MISTAKE AND CORRECTIVE ACTION WAS TAKEN.

    Description of Event or Problem · 1

    REPLY TO (B)(4). PRODUCT 6215 WAS SHIPPED IN A BOX THAT WAS LABELED FOR PRODUCT 6220. PRODUCT 6220 WAS CORRECT FOR THE PT. PRODUCT 6215 WAS NOT USED ON THE PT. THE MISLABELING WAS REPORTED TO ARC MEDICAL, INC. ON (B)(6) 2012, AND THE CORRECT PRODUCT WAS SHIPPED OVERNIGHT TO THE USER. THE INCORRECTLY LABELED PRODUCT WAS RETURNED TO ARC MEDICAL, INC. THE INDIVIDUALS INVOLVED IN THE INCORRECT PRODUCT BEING SHIPPED WERE INFORMED OF THE MISTAKE AND CORRECTIVE ACTION WAS TAKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMOFLO NEO TRACH NOSE WITH OXYGEN ADAPTER BYD ARC MEDICAL, INC. 6220 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1