BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALPEN POLISHER CUP

    MDR report key: 15882681 · Received November 29, 2022

    Report

    Report Number
    2416455-2022-00011
    Event Type
    Injury
    Date Received
    November 29, 2022
    Date of Event
    August 10, 2022
    Report Date
    November 29, 2022
    Manufacturer
    COLTENE WHALEDENT INC.
    Product Code
    EJR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO BATCH INFORMATION HAS BEEN PROVIDED BY THE CUSTOMER. COMPLAINT ANALYSIS FOR THE LAST 12 MONTHS IDENTIFIES NO ADDITIONAL COMPLAINTS FOR THIS PRODUCT. COMPLAINT ANALYSIS WAS PERFORMED DATING BACK TO JANUARY 1, 2013 TO REVIEW ALL SAP COMPLAINT DATA. THERE ARE NO ADDITIONAL COMPLAINTS FOR THIS FAILURE. NO PRODUCT WAS RETURNED FOR INVESTIGATION. THE CUSTOMER INDICATED THEY FAILED TO PROPERLY INSERT THE POLISHER INTO THE HANDPIECE. ROOT CAUSE: THIS POLISHER FEATURES A RIGHT-ANGLE LATCH AT THE BASE OF THE POLISHER. THIS LATCH SERVES TO SECURE THE DEVICE INTO THE HANDPIECE. FAILURE TO FULLY INSERT THE POLISHER INTO THE HANDPIECE, FULLY ENGAGE THE HOOK INTO THE LATCH, AND CONFIRM SECURITY PRIOR TO USE MAY RESULT IN THE POLISHER FALLING OUT WHEN USED AT HIGH SPEED. IN THIS INSTANCE THE CUSTOMER NOTED THEY FAILED TO PERFORM THIS STEP. THE ROOT CAUSE OF THIS COMPLAINT IS THE CUSTOMER FAILED TO PROPERLY SECURE THE DEVICE INTO THE HANDPIECE PRIOR TO USE. COMPLAINT ANALYSIS INDICATES THIS IS AN ISOLATED INCIDENT AT THIS TIME.

    Description of Event or Problem · 0

    POLISHING CONE (DRILL BIT) DISLODGED AND DROPPED INTO PATIENT'S MOUTH, PATIENT SWALLOWED. INSTITUTION RECENTLY MADE AWARE PT UNDERWENT COLONOSCOPY AND LATER PASSED DRILL BIT. COLTENE WAS MADE AWARE OF EVENT THROUGH MDR REPORT# MW5113020. ADDITIONAL INFORMATION WAS OBTAINED FROM THE DENTIST WHO STATED THAT THE BUR WAS NOT PROPERLY INSERTED INTO THE HANDPIECE AND THAT IS WHY THE BUR BROKE INTO PATIENT'S MOUTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2292450 ALPEN POLISHER CUP DENTAL POLISHER EJR COLTENE WHALEDENT INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention