BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HVE VALVE CLEANING BRUSH

    MDR report key: 11618876 · Received April 5, 2021

    Report

    Report Number
    MW5100568
    Event Type
    Injury
    Date Received
    April 5, 2021
    Date of Event
    March 19, 2021
    Report Date
    April 2, 2021
    Manufacturer
    DTE OREGON, INC. DBA FOREST DENTAL / FOREST DENTAL EQUIPMENT
    Product Code
    EHZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A STAFF MEMBER AT A DENTAL OFFICE WAS PERFORMING ROUTINE CLEANING OF THE HVE SUCTION VALVE TUBE WITH A CLEANING BRUSH PROVIDED BY THE MANUFACTURER WHEN THE BRUSH TIP PUNCTURED THE GLOVE AND THE FINGER WAS CUT. THE RESULT WAS A CUT ON THE FINGER FROM THE BRUSH TIP. THE STAFF MEMBER WAS USING THE BRUSH TO PERFORM CLEANING ON A MEDICAL DEVICE. SHE CLEANED THE INJURY AT THE OFFICE WITH SOAP, WATER, AND ANTISEPTIC WIPES AND THEN WRAPPED THE FINGER. THE STAFF MEMBER PROCEEDED TO THE HOSPITAL EMERGENCY ROOM WHERE TETANUS AND (B)(6) SHOTS WERE ADMINISTERED ALONG WITH A BLOOD PANEL. A FOLLOW UP TREATMENT WAS SCHEDULED FOR SIX WEEKS FROM THE DATE OF TREATMENT. THE STAFF MEMBER REPORTED NO PRIOR MEDICAL CONDITIONS. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513608 HVE VALVE CLEANING BRUSH EVACUATOR, ORAL CAVITY EHZ DTE OREGON, INC. DBA FOREST DENTAL / FOREST DENTAL EQUIPMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention