BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEOTECH NEOBAR

    MDR report key: 3760840 · Received April 9, 2014

    Report

    Report Number
    2025917-2014-00011
    Event Type
    Injury
    Date Received
    April 9, 2014
    Date of Event
    August 1, 2012
    Report Date
    August 20, 2012
    Manufacturer
    NEOTECH PRODUCTS, INC.
    Product Code
    CBH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED WAS NOT RETURNED TO THE MFR AS IT WAS DISPOSED OF BY THE DISTRIBUTOR AFTER TAKING A PICTURE. NO INVESTIGATION WAS PERFORMED, AS THIS IS A KNOWN ISSUE WITH NEOBARS MANUFACTURED ON THIS DATE. DUE TO CONCERNS OF THE NEOBARS DISLODGING FROM THE ADHESIVE TABS, THE MANUFACTURING OF ALL NEOBARS HAS SINCE CHANGED TO INCLUDE A WELDING PROCEDURE AND NO REPORTS OF TAB SEPARATION HAVE BEEN REPORTED TO THIS DAY. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PLASTIC BAR OF THE ET TUBE HOLDER SEPARATED FROM THE ADHESIVE TAB ON THE 1ST DAY OF USE. "THE PATIENT DID NOT GET SERIOUS DAMAGE"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212949 NEOTECH NEOBAR ET TUBE HOLDER CBH NEOTECH PRODUCTS, INC. N711 1239-11

    Patients

    Seq Age Sex Outcome Treatment
    1 21 DA Required Intervention ET TUBE WAS BEING USED WITH THE NEOBAR