BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POGO ONE STEP DIAMOND MICRO POLISHER

    MDR report key: 519916 · Received April 8, 2004

    Report

    Report Number
    2515379-2004-00182
    Event Type
    Injury
    Date Received
    April 8, 2004
    Date of Event
    March 5, 2004
    Report Date
    March 9, 2004
    Manufacturer
    DENTSPLY CAULK
    Product Code
    EHJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE DENTIST REPORTED CUTTING THE PT'S CHEEK WITH THE POLISHING DISC. THE PT DID NOT GO TO THE ER, BUT THE DENTIST ADMINISTERED ANTIBIOTICS AND STITCHES TO COMPLETE THE PROCEDURE. THE PT RETURNED TO THE DENTIST'S OFFICE FOR REMOVAL OF THE STITCHES AND IT WAS REPORTED THAT THE AREA WAS PROBABLY A LITTLE SORE, BUT SHOWED NO SIGNS OF INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POGO ONE STEP DIAMOND MICRO POLISHER DENTAL POLISHING INSTRUMENT EHJ DENTSPLY CAULK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention