BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HENRY SCHEIN INC

    MDR report key: 21330611 · Received February 7, 2025

    Report

    Report Number
    3003444492-2025-00003
    Event Type
    Malfunction
    Date Received
    February 7, 2025
    Date of Event
    January 9, 2025
    Report Date
    February 6, 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

    HENRY SCHEIN INC # 123887 - SURGICAL BUR FG 6 - LOT UNKNOWN - THE CUSTOMER REPORTS WHILE USING THESE BURS THE METAL IS SCATTERING IN THE SURGICAL SITE. IT COMPROMISES HEALING IF LEFT THERE. THE DOCTOR HAS SPENT A LOT OF TIME REMOVING THEM WHICH IS NOT EASY. THE DOCTOR THINKS IT HAPPENED MULTIPLE TIMES. NO ONE WAS HARMED, THE DOCTOR WAS ABLE TO RETRIEVE THE METAL PIECES OUT. AN EMAIL HAS ALREADY BEEN SENT WITH FOLLOW UP QUESTIONS AND WE HAVE YET TO HEAR BACK. - 1. HAS A SERIOUS PUBLIC HEALTH THREAT OCCURRED? NO - 2. HAS A DEATH OR UNANTICIPATED SERIOUS DETERIORATION IN STATE OF HEALTH OCCURRED? NO.

    Additional Manufacturer Narrative · 0

    HENRY SCHEIN INC#: 123887 - SURGICAL BUR FG 6 - LOT: UNKNOWN - THE CUSTOMER REPORTS WHILE USING THESE BURS THE METAL IS SCATTERING IN THE SURGICAL SITE. IT COMPROMISES HEALING IF LEFT THERE. THE DOCTOR HAS SPENT A LOT OF TIME REMOVING THEM WHICH IS NOT EASY. THE DOCTOR THINKS IT HAPPENED MULTIPLE TIMES. NO ONE WAS HARMED; THE DOCTOR WAS ABLE TO RETRIEVE THE METAL PIECES OUT. AN EMAIL HAS ALREADY BEEN SENT WITH FOLLOW UP QUESTIONS AND WE HAVE YET TO HEAR BACK. 1. HAS A SERIOUS PUBLIC HEALTH THREAT OCCURRED? NO. 2. HAS A DEATH OR UNANTICIPATED SERIOUS DETERIORATION IN STATE OF HEALTH OCCURRED? NO. INVESTIGATION/ROOT CAUSE: NO LOT NUMBER OR IMAGES WERE PROVIDED BY THE CUSTOMER. THE LOT NUMBER IS ESSENTIAL FOR REVIEWING OUR MANUFACTURING RECORDS. WITHOUT THIS INFORMATION, WE WILL BE UNABLE TO IDENTIFY THE ROOT CAUSE OF THE COMPLAINT, THEREFORE THIS COMPLAINT IS CONSIDERED UNJUSTIFIED. CC1231-UNABLE TO RECEIVE ANY RESPONSE FROM CUSTOMER.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTS WHILE USING THESE BURS THE METAL IS SCATTERING IN THE SURGICAL SITE. IT COMPROMISES HEALING IF LEFT THERE. THE DOCTOR HAS SPENT A LOT OF TIME REMOVING THEM WHICH IS NOT EASY. THE DOCTOR THINKS IT HAPPENED MULTIPLE TIMES. NO ONE WAS HARMED, THE DOCTOR WAS ABLE TO RETRIEVE THE METAL PIECES OUT. AN EMAIL HAS ALREADY BEEN SENT WITH FOLLOW UP QUESTIONS AND WE HAVE YET TO HEAR BACK.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTS WHILE USING THESE BURS THE METAL IS SCATTERING IN THE SURGICAL SITE. IT COMPROMISES HEALING IF LEFT THERE. THE DOCTOR HAS SPENT A LOT OF TIME REMOVING THEM WHICH IS NOT EASY. THE DOCTOR THINKS IT HAPPENED MULTIPLE TIMES. NO ONE WAS HARMED; THE DOCTOR WAS ABLE TO RETRIEVE THE METAL PIECES OUT. AN EMAIL HAS ALREADY BEEN SENT WITH FOLLOW UP QUESTIONS AND WE HAVE YET TO HEAR BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1299157 HENRY SCHEIN INC DENTAL BUR - SURGICAL BUR FG 6 EJL PRIMA DENTAL GROUP SURGICAL BUR FG 6 NOT KNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male