BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYGENIC

    MDR report key: 14572802 · Received June 2, 2022

    Report

    Report Number
    2416455-2022-00008
    Event Type
    Injury
    Date Received
    June 2, 2022
    Date of Event
    May 3, 2022
    Report Date
    June 1, 2022
    Manufacturer
    COLTENE WHALEDENT INC.
    Product Code
    EEF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: THIS COMPLAINT IS FOR MATERIAL H09960 #7 WINGED FIESTA CLAMP, BATCH K96855. INVENTORY ANALYSIS SHOWS NO REMAINING PRODUCT IN STOCK OF THIS BATCH NUMBER. SAP SHOWS THE STOCK OF THIS BATCH OF 2,000 WAS DEPLETED ON 2/24/2022. THE CLAMP WAS RETURNED FOR INVESTIGATION. THE CLAMP HAS A DATE CODE OF ND WHICH MEANS IT WAS MANUFACTURED IN 2018 JUL/AUG. THERE ARE MULTIPLE LARGE RUST SPOTS ON THE CLAMP THAT CAN BE SEEN WITH THE NAKED EYE. THE CLAMP WAS ALSO EXAMINED UNDER A MICROSCOPE. THE SURFACE OF THE CLAMP IS COVERED IN A WHITE RESIDUE. THE CLAMP BROKE ACROSS ONE OF THE RUST SPOTS. THERE ARE ALSO SMALL RUST SPOTS ON THE BREAK SURFACE. THE CUSTOMER CLEANS THEIR CLAMPS USING PRIMADENT PROTECT AND STERILIZATION FOR 30 MINUTES IN 132 °C. THE PH VALUE OF THIS CLEANING SOLUTION IS >11. THIS CLEANING PROCEDURE BEING USED BY THE CUSTOMER IS NOT THE CLEANING PROCEDURE STATED IN THE COLTENE IFU. THE IFU SPECIFICALLY STATES A PH NEUTRAL CLEANING SOLUTION SHOULD BE USED. ALSO, THE CLAMPS SHOULD BE STERILIZED FOR 15 MINUTES AT 132°C USING A GRAVITY AUTOCLAVE OR 4 MINUTES AT 132°C USING A PRE-VACUUM AUTOCLAVE. THE PRIMADENT PROTECT SOLUTION AND THE HIGH STERILIZATION TIME MAY HAVE A NEGATIVE IMPACT ON THE PRODUCT LIFE AND LIKELY ATTRIBUTED TO THE EARLY DEGRADATION AND BREAKAGE OF THE CLAMP. ROOT CAUSE: BREAK CAUSED BY MATERIAL DEGRADATION. MATERIAL DEGRADATION DUE TO CUSTOMER CLEANING PROCEDURE.

    Description of Event or Problem · 0

    ON 5/3/2022 THE CUSTOMER STATED THE FOLLOWING: DENTAL CLAMPS BROKEN AFTER 2 USES IN PATIENT MOUTH. WASHING IN SOLUTION. DISINFECTED IN PRIMADENT PROTECT. STERILIZATION 30 MINUTES IN 132. USED ONLY ONE 2 TIME ( SINCE PURCHASED 10/2021). NOBODY WAS INJURED. NO SURGICAL INTERVENTION. BECAUSE A SIMILAR EVENT WAS PREVIOUSLY REPORTED WHERE THE DENTAL CLAMP BROKE DURING TREATMENT AND THE DENTAL DAM CAME OFF OF THE TOOTH CAUSING SALIVA TO INTRUDE AND TREATMENT TO BE RESTARTED, IF THIS MALFUNCTION WERE TO RECUR, AN INJURY COULD HAPPEN. OUT OF AN ABUNDANCE OF CAUTION AND PER 21 CFR 803, THIS EVENT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2161119 HYGENIC DENTAL DAM CLAMP EEF COLTENE WHALEDENT INC. K96855

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention