BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYGENIC

    MDR report key: 15365990 · Received September 6, 2022

    Report

    Report Number
    2416455-2022-00010
    Event Type
    Injury
    Date Received
    September 6, 2022
    Date of Event
    July 8, 2022
    Report Date
    August 26, 2022
    Manufacturer
    COLTENE/WHALEDENT, INC.
    Product Code
    EEF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2022, CUSTOMER STATED THAT MOLARS CLAMPS SETS 13A AND 12A WERE USED ON MAXILLARY MOLAR 4 AND BOTH SETS FRACTURED DURING USE, WITHOUT WARNING BETWEEN 1ST USAGE AND 10TH USAGE. ON ALL OCCASIONS, CLAMPS FLOSSED AND RETRIEVED WITHOUT INCIDENT. ALL CLAMPS RUSTED WITH SODIUM HYPOCHLORITE USE (5.25%). ADDITIONAL INFORMATION WAS PROVIDED ON 08/08/2022 AS FOLLOWS: THE CLAMPS BROKE DURING THE PROCEDURE. THE FIRST ONE AT ABOUT 15-30 MINUTES INTO THE PROCEDURE, AND THE SECOND ONE AT ABOUT ONE HOUR INTO THE PROCEDURE. ON BOTH OCCASIONS, THE DENTAL DAM CAME OFF THE TOOTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2182822 HYGENIC DENTAL DAM CLAMP EEF COLTENE/WHALEDENT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention