BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIACOMP FEATHER LITE

    MDR report key: 6094395 · Received November 10, 2016

    Report

    Report Number
    1032227-2016-00011
    Event Type
    Injury
    Date Received
    November 10, 2016
    Date of Event
    October 17, 2016
    Report Date
    November 10, 2016
    Manufacturer
    EVE ERNST VETTER GMBH
    Product Code
    EJQ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NV, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: NO PRODUCT WAS RETURNED FOR EVALUATION. IT APPEARS TO BE UNINTENDED USER ERROR. THIS IS AN ISOLATED OCCURRENCE.

    Description of Event or Problem · 1

    AFTER PLACING A SIMPLE RESIN TOOTH #19, THE DOCTOR STARTED POLISHING THE RESIN USING A FLDC5M FEATHER LITE INTRA-ORAL COMPOSITE POLISHER - GREEN. UPON POLISHING, THE DISC ENGAGED THE FLOOR OF THE MOUTH AND PROCEEDED TO WRAP ITSELF AROUND THE TISSUE. DOCTOR CLAIMS THAT THERE WAS NOTHING THE HE COULD DO TO STOP THE INCIDENT UNTIL THE MOMENTUM OF THE HANDPIECE DISCONTINUED. ONLY THEN WAS THE DOCTOR ABLE TO UNRAVEL THE TISSUE FROM THE DISC. A LACERATION WAS LEFT BEHIND APPROXIMATELY 1.3CM BY 7MM. THE DOCTOR REFERRED THE PATIENT TO AN ORAL SURGEON FOR REPAIR. THE DOCTOR NOTED ON (B)(6) 2016 THAT THE PATIENT WAS FINE.

    Description of Event or Problem · 1

    FROM E-MAIL. AFTER PLACING A SIMPLE RESIN TOOTH #19, THE DOCTOR STARTED POLISHING THE RESIN USING A FLDC5M FEATHER LITE INTRA-ORAL COMPOSITE POLISHER - GREEN. UPON POLISHING, THE DISC ENGAGED THE FLOOR OF THE MOUTH AND PROCEEDED TO WRAP ITSELF AROUND THE TISSUE. DOCTOR CLAIMS THAT THERE WAS NOTHING THE HE COULD DO TO STOP THE INCIDENT UNTIL THE MOMENTUM OF THE HANDPIECE DISCONTINUED. ONLY THEN WAS THE DOCTOR ABLE TO UNRAVEL THE TISSUE FROM THE DISC. A LACERATION WAS LEFT BEHIND APPROXIMATELY 1.3CM BY 7MM. THE DOCTOR REFERRED THE PATIENT TO AN ORAL SURGEON FOR REPAIR. THE DOCTOR NOTED ON OCT/21/2016 THAT THE PATIENT WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743118 DIACOMP FEATHER LITE DENTAL POLISHER EJQ EVE ERNST VETTER GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention