BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HENRY SCHEIN INC

    MDR report key: 21092578 · Received January 7, 2025

    Report

    Report Number
    3003444492-2025-00001
    Event Type
    Malfunction
    Date Received
    January 7, 2025
    Date of Event
    December 13, 2024
    Report Date
    January 7, 2025
    Manufacturer
    PRIMA DENTAL GROUP
    Product Code
    EJL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS AN INITAL REPORT. FURTHER UPDATES WILL BE MADE ONCE THE DEFECTIVE DEVICE IS RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    INVESTIGATION WAS MADE ON THE MANUFACTURING RECORDS FOR THE INFORMED LOT NUMBER AND NO ABNORMALITY WAS FIND. AS THERE ARE NO PARTS TO BE TESTED, WE'RE NOT ABLE TO FIND THE ROOT CAUSE. THEREFORE, THE COMPLAINT IS CONSIDERED UNJUSTIFIED. EMAIL FROM CUSTOMER CONFIRMING TO SAMPLES WILL BE RETURNED FOR INVESTIGATION ATTACHED.

    Description of Event or Problem · 0

    HENRY SCHEIN INC - 123675 - ORAL SURGERY BUR SHANK 5 - 1126804 - CROUND023SV - LOT: 1503301 - THE CUSTOMER REPORTS THAT A BUR BROKE IN A PATIENT'S MOUTH. IT WAS REMOVED WITH SUCTION.

    Description of Event or Problem · 0

    HENRY SCHEIN INC - 123675 - ORAL SURGERY BUR SHANK 5 - 1126804 - CROUND023SV - LOT: 1503301 - THE CUSTOMER REPORTS THAT A BUR BROKE IN A PATIENT'S MOUTH. IT WAS REMOVED WITH SUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835443 HENRY SCHEIN INC DENTAL BUR EJL PRIMA DENTAL GROUP 1126804 1503301

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention