BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEN AIRE DRILL

    MDR report key: 3820042 · Received May 6, 2014

    Report

    Report Number
    3820042
    Event Type
    Malfunction
    Date Received
    May 6, 2014
    Date of Event
    April 18, 2014
    Report Date
    May 6, 2014
    Manufacturer
    KLS MARTIN LP
    Product Code
    DZA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BUR WAS SEATED AND LOCKED. THE WHOLE HANDPIECE HEATED AND BURNED PATIENT'S LIP.====================== MANUFACTURER RESPONSE FOR BEN AIRE HAND PIECE, BEN AIRE DRILL (PER SITE REPORTER).====================== THE HANDPIECE HAS BEEN SENT TO THE MANUFACTURER FOR INSPECTION AND REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271855 BEN AIRE DRILL DRILL, DENTAL, INTRAORAL DZA KLS MARTIN LP 1600436 *

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR