BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYGENIC

    MDR report key: 14552256 · Received May 31, 2022

    Report

    Report Number
    2416455-2022-00007
    Event Type
    Injury
    Date Received
    May 31, 2022
    Date of Event
    May 3, 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

    TWO CLAMPS WERE RETURNED FOR INVESTIGATION. THE FOLLOWING DATE CODE WAS OBTAINED FROM BOTH CLAMPS: RE (MANUFACTURED 2020 SEPTEMBER/OCTOBER). THE PAINT BAND IS GOOD CONDITION ON BOTH CLAMPS. BOTH CLAMPS BROKE TO THE LEFT OF THE HYGIENIC LOGO. THE CLAMP CONTAINS SUBSTANTIAL AMOUNT OF WHITE RESIDUE ON THE SURFACE OF THE CLAMP VISIBLE TO THE NAKED EYE. THE CLAMP ALSO CONTAINS RUST SPOTS VISIBLE TO THE NAKED EYE ON THE UNDERSIDE OF THE CLAMP BAND. THE CLAMP WAS EXAMINED UNDER A MICROSCOPE WHERE ADDITIONAL SPOTS OF RUST WERE VISIBLE ALONG THE BREAK SURFACE ALONG WITH DARK GRAY DISCOLORATION. THE CUSTOMER'S COMPLAINT IS CONFIRMED. THE CUSTOMER'S CLEANING PROCESS INCLUDING EQUIPMENT IS UNKNOWN. THE CUSTOMER DID INDICATE THE CLAMPS WERE DISINFECTED WITH PRIMADENT PROTECT, AN ALKALINE BASED DETERGENT. THE CONDITION OF THE BREAK SURFACES INDICATE 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 CLAMPS 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 (B)(6) 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 (B)(6) 2021). NOBODY WAS INJURED. NO SURGICAL INTERVENTION. BROKEN PIECES OF THE CLAMP WAS ABLE TO LOCATED AND REMOVED FROM THE PATIENT'S MOUTH. 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
    2811335 HYGENIC DENTAL DAM CLAMP EEF COLTENE WHALEDENT INC. K69234

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention