BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRILL 3334800 VISAO 80K HANDPIECE

    MDR report key: 3201239 · Received July 2, 2013

    Report

    Report Number
    1045254-2013-00440
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 10, 2013
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    ERL
    PMA / PMN Number
    K011321
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). UPDATED EVENT DESCRIPTION: THIS PATIENT IS FEMALE WHO COMPLAINS OF A HISTORY OF A PALATINE TORUS. DURING THE CASE, PER THE SURGEON, THE SHAFT OF THE DRILL ABOVE THE DRILL BUR GENERATED SIGNIFICANT HEATING CAUSING A RIGHT BUCCAL MUCOSAL BURN THAT WAS SECOND DEGREE. BACITRACIN OINTMENT WAS APPLIED TO THIS AREA. THE PATIENT WAS DISCHARGED HOME. IT HAS BEEN CONFIRMED THAT THE PATIENT IS STILL HEALING. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONCOMITANT PRODUCT: 3334635, GUARD 3334635 VISAO BUR W/IRRIGATION, LOT AND S/N NOT PROVIDED. ERL 510K: K983224. (B)(4). NO EVALUATION SUMMARY AVAILABLE, DEVICE NOT RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THIS PATIENT IS FEMALE WHO COMPLAINS OF A HISTORY OF A PALATINE TORUS. DURING THE CASE, PER THE SURGEON, THE SHAFT OF THE DRILL ABOVE THE DRILL BUR GENERATED SIGNIFICANT HEATING CAUSING A RIGHT BUCCAL MUCOSAL BURN THAT WAS SECOND DEGREE. BACITRACIN OINTMENT WAS APPLIED TO THIS AREA. THE PATIENT WAS DISCHARGED HOME. IT HAS BEEN CONFIRMED THAT THE PATIENT IS STILL HEALING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT SUSTAINED AN ORAL MUCOSAL BURN WHEN THE DRILL WAS BEING USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301542 DRILL 3334800 VISAO 80K HANDPIECE DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL MEDTRONIC XOMED, INC. 3334800 71603100

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Other