BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HENRY SCHEIN INC

    MDR report key: 22292405 · Received June 19, 2025

    Report

    Report Number
    3003444492-2025-00004
    Event Type
    Malfunction
    Date Received
    June 19, 2025
    Date of Event
    May 8, 2025
    Report Date
    June 19, 2025
    Manufacturer
    PRIMA DENTAL GROUP
    Product Code
    EJL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINANT UNABLE TO PROVIDE WHICH PART NUMBER CAUSED THE INCIDENT, NOR COULD THEY PROVIDE ANY LOT NUMBERS. DEVICES ARE UNABLE TO BE RETURNED TO THE MANUFACTURER FOR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    COMPLAINANT UNABLE TO PROVIDE WHICH PART NUMBER CAUSED THE INCIDENT, NOR COULD THEY PROVIDE ANY LOT NUMBERS. DEVICES ARE UNABLE TO BE RETURNED TO THE MANUFACTURER FOR INVESTIGATION. INITIAL CHECK THROUGH THE RETURNED BOX FOUND 3 DIFFERENT PRODUCTS, FG557, FG558 AND FG330. DEVICE WERE RETURNED AND AN INVESTIGATION WAS ABLE TO BE CARRIED OUT BURS TESTED ON THE TEST RIG AND NO BURS WERE FOUND TO LEAVE THE HANDPIECE. DIMENSIONAL CHECK WAS PERFORMED ON RETURNED PARTS AND THE RESULTS WERE SIMILAR COMPARED TO APPROVED PARTS FROM STOCK. INVESTIGATION HAS BEEN MADE ON THE MANUFACTURING RECORDS FOR THE INFORMED LOT NUMBER AND NO ABNORMALITY WAS FIND. THEREFORE, THE COMPLAINT IS CONSIDERED UNJUSTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTS THAT ON (B)(6) 2025 A 6 YEAR OLD PATIENT THE DOCTOR WAS DOING CROWNS ON S AND T W/PULP. WHILE THE DOCTOR WAS DRILLING, THE BUR CAME OUT AND CUT THE INSIDE OF THE CHILD'S CHEEK. THE DR. WAS ABLE TO STOP THE BLEEDING, AND WANTED TO SEND THE CHILD TO THE HOSPITAL, BUT AFTER SPEAKING TO MOM, THEY WERE GOING TO MONITOR THE CUT OVER A FEW DAYS. MOM WAS CALLED AND SHE STATED THAT IT WAS HEALING. COMMON BURS USED (NO LOT#'S AVAILABLE) FG557 (ITEM 1014491) AND FG330 (ITEM #1010237). THE HANDPIECE IS HS ITEM CODE: 5700108, MAXIMA ELITE MINI.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTS THAT ON (B)(6) 2025 A 6-YEAR-OLD PATIENT THE DOCTOR WAS DOING CROWNS ON S AND T W/PULP. WHILE THE DOCTOR WAS DRILLING, THE BUR CAME OUT AND CUT THE INSIDE OF THE CHILD'S CHEEK. THE DR. WAS ABLE TO STOP THE BLEEDING, AND WANTED TO SEND THE CHILD TO THE HOSPITAL, BUT AFTER SPEAKING TO MOM, THEY WERE GOING TO MONITOR THE CUT OVER A FEW DAYS. MOM WAS CALLED AND SHE STATED THAT IT WAS HEALING. COMMON BURS USED (NO LOT#'S AVAILABLE) FG557 (ITEM 1014491) AND FG330 (ITEM #1010237). THE HANDPIECE IS HS ITEM CODE: 5700108, MAXIMA ELITE MINI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1684229 HENRY SCHEIN INC DENTAL BUR EJL PRIMA DENTAL GROUP NOT KNOW NOT KNOW

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Unknown