BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYGENIC

    MDR report key: 14552308 · Received May 31, 2022

    Report

    Report Number
    2416455-2022-00009
    Event Type
    Injury
    Date Received
    May 31, 2022
    Date of Event
    May 4, 2022
    Report Date
    May 31, 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: THE COMPLAINT IS FOR MATERIAL H09963 #12A WINGED FIESTA CLAMP, QTY. NO BATCH INFORMATION WAS PROVIDED SO AN INVENTORY ANALYSIS CANNOT BE PERFORMED. ONE CLAMP WAS RETURNED FOR INVESTIGATION. THE FOLLOWING DATE CODE WAS OBTAINED FROM THE CLAMP: SA (MANUFACTURED 2021 JANUARY/FEBRUARY). THE PAINT BAND IS ALMOST COMPLETELY WORN OFF OF THE CLAMP. THE CLAMP BROKE NEAR THE CENTER OF THE PAINT BAND. THE CLAMP CONTAINS SUBSTANTIAL AMOUNT OF WHITE RESIDUE ON THE FACE OF THE CLAMP AND ON THE UNDERSIDE OF THE CLAMP BAND VISIBLE TO THE NAKED EYE. THE CLAMP DOES CONTAIN A LARGE SPOT OF DISCOLORATION ALONG THE BREAK SURFACE THAT IS VISIBLE TO THE NAKED EYE. THE CLAMP WAS EXAMINED UNDER A MICROSCOPE WHERE A FEW SPOTS OF RUST WERE VISIBLE ALONG THE BREAK SURFACE. THE CUSTOMER'S COMPLAINT IS CONFIRMED. THE CUSTOMER'S CLEANING PROCESS INCLUDING EQUIPMENT AND SOLUTIONS IS UNKNOWN. HOWEVER, THE CONDITION OF THE BREAK SURFACE INDICATES THAT THE CUSTOMER LIKELY USED A SOLUTION IN THEIR CLEANING PROCESS WHICH WAS ABLE TO CORROSIVELY PENETRATE THE MATERIAL. USE OF A CORROSIVE CLEANING SOLUTION CAN CAUSE THE DEGRADATION OF THE MATERIAL OF THE CLAMP. WHEN POOR RINSING PRACTICES ARE COUPLED WITH A CORROSIVE SOLUTION AND AUTOCLAVE STERILIZATION, DEGRADATION OF THE MATERIAL IS TYPICAL AND ACCELERATED. IT IS MOST LIKELY THAT THE DEGRADATION OF THE MATERIAL OF THE CLAMP CAUSED THE BREAKAGE. CLAMPS UNDERGO AN AMOUNT OF STRESS WHEN THEY ARE EXPANDED UNDER NORMAL USE. DEGRADATION OF THE MATERIAL CAUSES THEM TO BE WEAKER AND UNABLE TO WITHSTAND THE FORCE OF EXPANSION. TO PREVENT DEGRADATION OF THE MATERIAL, CLAMPS NEED TO BE CLEANED WITH A PH NEUTRAL SOLUTION AND TO BE RINSED PROPERLY WITH WATER AFTER CLEANING. DE-IONIZED IS PREFERABLE FOR RINSING AS TAP WATER MAY CONTAIN HARSH ALKALINE CHEMICALS (CHLORIDES) ADDED TO KILL BACTERIA. ROOT CAUSE: BREAK CAUSED BY MATERIAL DEGRADATION

    Description of Event or Problem · 0

    ON 5/4/2022 THE CUSTOMER STATED THAT THE CLAMP BROKE DURING USE. ON 5/9/2022 THE CUSTOMER STATED THAT THE CLAMP BROKE DURING THE PROCEDURE, THE CLAMP WAS ABLE TO BE RETRIEVED. THERE WAS NO PATIENT OR USER INJURY. IT DID NOT REQUIRE SURGICAL INTERVENTION. THE DENTAL DAM CAME OFF OF THE TOOTH WHEN THE CLAMP BROKE. 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
    2714100 HYGENIC DENTAL DAM CLAMP EEF COLTENE WHALEDENT INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention