BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HALL (LINVA TEC)

    MDR report key: 513946 · Received March 1, 2004

    Report

    Report Number
    513946
    Event Type
    Injury
    Date Received
    March 1, 2004
    Date of Event
    November 26, 2003
    Report Date
    February 27, 2004
    Manufacturer
    LINVATEC
    Product Code
    DZI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    PT SUFFERED A BURN TO LOWER RIGHT LIP WHEN DENTAL HANDPIECE MALFUNCTIONED (OVERHEATED) DURING THE EXTRACTION OF 3RD MOLAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HALL (LINVA TEC) DENTAL HANDPIECE DZI LINVATEC SURGAIRTOME TWO #5058-001 *

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other| R PATIENT REFERRED TO PLASTIC SURGEON.