BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAWE BRISTLE BRUSHES NYLON

    MDR report key: 6056135 · Received October 25, 2016

    Report

    Report Number
    8031023-2016-00001
    Event Type
    Injury
    Date Received
    October 25, 2016
    Date of Event
    February 19, 2016
    Report Date
    August 11, 2025
    Manufacturer
    KERR HAWE SA
    Product Code
    EHL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS INCORRECTLY SUBMITTED ON 24. MARCH.2016. IN ADDITION, UPDATE B3: DATE OF EVENT TO 02/19/2016 AND B4: DATE OF THIS REPORT TO 02/29/2016 THE PATIENT HAD UNDERGONE AN ENDOSCOPIC PROCEDURE TO RETRIEVE THE BRUSH FROM THE THROAT BY FORCEPS. MEDICATIONS SUCH AS: GASCON 2% 5 ML, XYLOCAINE 2% 3 ML, ANETOCAINE JELLY 2% 10 ML, PRIVINA 0.05% 1 ML, XYLOCAINE 4% 1 ML WERE PRESCRIBED AT THE TIME OF THE ENDOSCOPIC PROCEDURE. THE PRODUCT ASSOCIATED WITH THE INCIDENT IS CLASSIFIED AS NON-STERILE AND SINGLE-USE PRODUCT. INVESTIGATION OF THE INCIDENT FOUND THAT THE DENTIST HAD ROUTINELY REUSE THE BRUSHES AFTER AUTOCLAVING THEM. KAVO DENTAL SYSTEM JAPAN EVALUATED THE PRODUCT AND FOUND THE BRUSH CORRODED AND HAD CHIPPED NOTCHES. PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR FURTHER INVESTIGATION. TO-DATE, THE PATIENT IS REPORTED TO BE DOING WELL AND NO FOLLOW-UP APPOINTMENT IS REQUIRED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) REVEALED THAT THERE WERE NO DEVIATIONS FROM THE MANUFACTURING PROCESS. 11 AUGUST 2025: RESUBMISSION OF THIS REPORT. THE DATE OF THE REPORT HAS BEEN CHANGED TO 11 AUGUST 2025 WITH THE INITIAL SUBMISSION DATE OF 29 FEBRUARY 2016.

    Description of Event or Problem · 0

    A DOCTOR'S OFFICE ALLEGED A PATIENT HAD SWALLOWED A HAWE BRISTLE NYLON BRUSH 835/50 INT THAT CAME OFF FROM THE HANDPIECE DURING A TEETH CLEANING PROCEDURE. THE PATIENT HAD UNDERGONE AN ENDOSCOPIC PROCEDURE TO RETRIEVE THE BRUSH FROM THE THROAT BY FORCEPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707430 HAWE BRISTLE BRUSHES NYLON POINT, ABRASIVE EHL KERR HAWE SA 3732101

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Unknown Required Intervention CONTR-ANGLE (OSADA ELECTRIC CO., LTD).| PROPHY-PASTE 'PURETECT' (MUTUMIKAGAKU).