BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BURKHART LABEL SALIVA EJECTOR

    MDR report key: 4946020 · Received July 22, 2015

    Report

    Report Number
    MW5044821
    Event Type
    Injury
    Date Received
    July 22, 2015
    Date of Event
    June 29, 2015
    Report Date
    July 22, 2015
    Manufacturer
    BURKHART DENTAL SUPPLY
    Product Code
    DYN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    TIP FROM (B)(6) PRIVATE LABEL SALIVA EJECTOR (PRODUCT #(B)(4)) WAS SEPARATED WHILE SUCTIONING THE PATIENT DURING A DENTAL PROCEDURE. PATIENT ASPIRATED THE TIP. HE WAS SENT TO HOSPITAL FOR A BRONCHOSCOPY TO REMOVE THE TIP FROM HIS LUNG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475155 BURKHART LABEL SALIVA EJECTOR SALIVA EJECTOR DYN BURKHART DENTAL SUPPLY 04-10-151

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| L