BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSLUX 2WAVE

    MDR report key: 9565816 · Received January 8, 2020

    Report

    Report Number
    1821514-2020-00001
    Event Type
    Injury
    Date Received
    January 8, 2020
    Date of Event
    December 10, 2019
    Report Date
    January 6, 2020
    Manufacturer
    KULZER GMBH
    Product Code
    EBZ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    DA
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DENTIST WANTED TO INSERT THE BATTERY INTO THE DEVICE FOR THE FIRST START UP. SHE HAS REMOVED THE PROTECTIVE FOIL AROUND THE BATTERY PACK BEFORE INSERTING THE RECHARGEABLE BATTERY. VERY PROBABLY, A SHORTAGE OF THE BATTERY OCCURRED DURING INSERTION AND THE SHORTAGE WIRE GOT VERY HOT. BY THE SCARE, THE DEVICE FELL TO THE GROUND AND SEPARATED INTO PIECES. THE DENTIST SUFFERED A VERY SMALL, 3RD DEGREE BURN ON HER LEFT HAND MIDDLE FINGER. SHE WENT TO SEE A DOCTOR AND HAD TO CLOSE THE DENTAL SURGERY FOR THAT AFTERNOON. OUT OF AN ABUNDANCE OF CAUTION THIS INCIDENT IS REPORTABLE ACCORDING TO 21 CFR 803. THE FDA DEFINES THIS AS A SERIOUS INJURY. AS THE DENTIST REPORTS SEEKING SECONDARY CARE AND THE LIKELY HOOD OF THE REOCCURRENCE IF THE FOIL/PACKAGING AROUND THE BATTERY IS REMOVED. (B)(4).

    Description of Event or Problem · 1

    SMALL 3RD DEGREE BURN ON DENTIST'S FINGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28777 TRANSLUX 2WAVE ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION EBZ KULZER GMBH N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other