BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSLUX

    MDR report key: 9591322 · Received January 15, 2020

    Report

    Report Number
    3005665377-2020-00001
    Event Type
    Injury
    Date Received
    January 15, 2020
    Date of Event
    December 10, 2019
    Report Date
    January 15, 2020
    Manufacturer
    KULZER GMBH - HQ
    Product Code
    EBZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. THIS INCIDENT IS REPORTED OUT OF AN ABUNDANCE OF CAUTION ACCORDING TO 21 CFR 803 AS THE FDA MIGHT DEFINE THIS AS A SERIOUS INJURY. THIS IS ASSUMED TO THE FACT THAT THE DENTIST REPORTS SEEKING SECONDARY MEDICAL CARE FOR HIS SLIGHT BURN AND THERE IS A LIKELY HOOD OF REOCCURRENCE IF THE USER DEFOILS/ UNPACKS THE PROTECTIVE FOIL AROUND THE LITHIUM ION RECHARGEABLE BATTERY PACK.

    Description of Event or Problem · 1

    VERY SMALL 3RD DEGREE BURN ON DENTIST'S FINGER AT TRIAL OF INITIAL START-UP OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54483 TRANSLUX ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION, EBZ KULZER GMBH - HQ 2WAVE N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other