BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCLEAN ULTRASONIC SCALER

    MDR report key: 17799662 · Received September 22, 2023

    Report

    Report Number
    3007007357-2023-00011
    Event Type
    Injury
    Date Received
    September 22, 2023
    Date of Event
    August 16, 2023
    Report Date
    January 11, 2024
    Manufacturer
    TTBIO CORP
    Product Code
    ELC
    UDI-DI
    00304040155837
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NV, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AMENDED THE FORMAL INVESTIGATION REPORT TO SHOW EVALUATION RESULTS, ROOT CAUSE OF FAILURE, AND RESULTING ACTIONS.

    Description of Event or Problem · 0

    A 33 YEAR OLD HYGIENE ASSISTANT WAS CLEANING THE ROOM FOLLOWING A HYGIENE APPOINTMENT. WHEN SHE PICKED UP THE INSERT SHE RECEIVED A BURN ON HER FINGER. THE ASSISTANT DID NOT NEED FURTHER MEDICAL ATTENTION, BUT ITEM HAS POTENTIAL TO BURN PATIENTS OR OTHER STAFF MEMBERS. BOTH ITEMS ARE EXTREMELY HOT AFTER USE. THIS HAPPENED ON (B)(6) 2023 AT 11:30 A.M.

    Description of Event or Problem · 0

    A 33 YEAR OLD HYGIENE ASSISTANT WAS CLEANING THE ROOM FOLLOWING A HYGIENE APPOINTMENT. WHEN SHE PICKED UP THE INSERT SHE RECEIVED A BURN ON HER FINGER. THE ASSISTANT DID NOT NEED FURTHER MEDICAL ATTENTION, BUT ITEM HAS POTENTIAL TO BURN PATIENTS OR OTHER STAFF MEMBERS. BOTH ITEMS ARE EXTREMELY HOT AFTER USE. THIS HAPPENED ON 08/16/2023 AT 11:30 A.M.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1873233 ACCLEAN ULTRASONIC SCALER HANDPIECE ELC TTBIO CORP ACCLEAN ULTRASONIC SCALER 00304040155837
    2234642 ACCLEAN ULTRASONIC SCALER HANDPIECE ELC TTBIO CORP ACCLEAN ULTRASONIC SCALER 00304040155837

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female Other