BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DENTAL DRILL

    MDR report key: 11875006 · Received May 24, 2021

    Report

    Report Number
    MW5101527
    Event Type
    Injury
    Date Received
    May 24, 2021
    Date of Event
    May 19, 2021
    Report Date
    May 20, 2021
    Manufacturer
    UNK
    Product Code
    DZA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    WHILE HAVING A CROWN BUILD UP PERFORMED BY A DENTIST, I SUSTAINED, AT MINIMUM, SECOND DEGREE BURNS ON MY LIP DUE TO A DENTAL DRILL OVER HEATING. BLISTERING AND CHANGE OF SKIN COLOR WAS NOTED BY THE PATIENT (MYSELF) WITHIN MINUTES AFTER THE CONCLUSION OF THE APPOINTMENT. DENTAL STAFF DID NOT MENTION OROMUCOSAL DAMAGE TO THE PATIENT DURING OR AT THE END OF THE PROCEDURE. BURNING WAS NOT FELT DURING THE PROCEDURE DUE TO LOCAL ANESTHESIA. GIVEN THAT THE INJURY OCCURRED IN THE EVENING, AND THE DENTAL OFFICE WAS CLOSED AT THE TIME THE INJURY WAS NOTICED BY THE PATIENT, THE DENTAL OFFICE WAS INFORMED THE FOLLOWING MORNING. THE PATIENT REQUIRED FOLLOW UP WITH A PHYSICIAN THE FOLLOWING MORNING; THE INJURY IS BEING MONITORED FOR INFECTION. ADDITIONAL MEDICAL FOLLOW UP IS LIKELY TO BE NEEDED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765382 DENTAL DRILL DRILL, DENTAL, INTRAORAL DZA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention