BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BITE GARD MOLAR BITE BLOCK

    MDR report key: 7112203 · Received December 13, 2017

    Report

    Report Number
    7112203
    Event Type
    Malfunction
    Date Received
    December 13, 2017
    Date of Event
    November 22, 2017
    Report Date
    December 6, 2017
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    JXL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE WAKING UP A PATIENT FROM ANESTHESIA, THE BITE BLOCK BROKE OFF IN THE PATIENT'S MOUTH. THE END PORTION OF THE BITE BLOCK WAS ABLE TO BE REMOVED BY THE ANESTHESIA PROVIDER SAFELY. THIS WOULD HAVE BEEN AN ASPIRATION RISK IF THE BROKEN PIECE WAS NOT DISCOVERED AND PROMPTLY REMOVED. THE PIECES OF THE BITE BLOCK WERE SAVED AND IMAGES WILL BE ATTACHED TO THIS REPORT. PER SITE REPORTER: AWAITING MANUFACTURER RESPONSE. THIS DEVICE WILL BE RETURNED TO THE MANUFACTURER FOR FAILURE ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    892860 BITE GARD MOLAR BITE BLOCK AIRWAY, ORAL, BITE BLOCK JXL TELEFLEX MEDICAL N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR