BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYGENIC

    MDR report key: 7800496 · Received August 21, 2018

    Report

    Report Number
    2416455-2018-00002
    Event Type
    Malfunction
    Date Received
    August 21, 2018
    Date of Event
    June 18, 2018
    Report Date
    August 29, 2018
    Manufacturer
    COLTENE WHALEDENT INC.
    Product Code
    EEF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    THE ISSUE WAS REPORTED TO BE, B2 CLAMP AFTER PUTTING IT ON THE TOOTH IN MINUTES JUMPED IN MY FACE AND INJURED MY PATIENT. UPON FURTHER INVESTIGATION IT WAS FOUND THAT THE CLAMP BROKE IN THE PATIENT'S MOUTH AND CAUSED A SMALL CUT. PRODUCT WAS NOT RETURNED, HOWEVER SEVERAL PICTURES WERE PROVIDED. THE PICTURES DO NOT SHOW THE CLAMP DATE CODE NOR WAS A BATCH NUMBER PROVIDED, SO IT IS UNKNOWN WHEN THE CLAMP WAS MANUFACTURED. FROM THE PICTURES, THE CLAMP APPEARS TO BE TARNISHED AND HAS RESIDUE ON THE SURFACE. THE SURFACE OF THE BREAK SPECIFICALLY LOOKS BLACK. THIS SUGGESTS THAT THE CLEANING SOLUTION USED IS HARMFUL TO THE METAL AND THAT THE CLAMPS ARE NOT GETTING PROPERLY RINSED AFTER CLEANING. IT WAS DETERMINED THAT THE CUSTOMER USES UNODENT ENZYMATIC ULTRASONIC ECONOMY REFILL TO CLEAN THE CLAMP. THIS CLEANING SOLUTION CONTAINS DIDECYLDIMETHYL AMMONIUM CHLORIDE, WHICH IS CAUSTIC. THE RESIDUE ON THE CLAMP SUGGESTS IT WAS NOT BEING RINSED PROPERLY. IMPROPER RINSING AFTER USING A CAUSTIC CLEANING SOLUTION LEAVES THE CAUSTIC SOLUTION ON THE SURFACE WHICH LEADS TO DEGRADATION OF THE METAL. THE BLACK COLOR ON THE SURFACE OF THE BREAK INDICATES THE PRESENCE OF CAUSTIC STRESS CORROSION (CSC), WHICH IS THE MOST PROBABLE CAUSE OF THE CLAMP BREAKAGE. TO PREVENT CSC, THE CLAMPS NEED TO BE RINSED WITH WATER AFTER CLEANING DE-IONIZED IS PREFERABLE AS TAP WATER MAY CONTAIN HARSH ALKALINE CHEMICALS (CHLORIDES) ADDED TO KILL BACTERIA. INSUFFICIENT RINSING AFTER USING CAUSTIC CHEMICALS IN THE CLEANING PROCESS PRIOR TO AUTOCLAVE STERILIZATION WILL SIGNIFICANTLY INCREASE THE CHANCE OF PREMATURE BREAKAGE AS THE HEAT FROM THE AUTOCLAVE WILL SPEED UP THE DEGRADATION PROCESS. THIS IS THE ONLY COMPLAINT FOR THIS PART NUMBER IN THE PAST 12 MONTHS. RISK ASSESSMENT: PROBABILITY: IMPROBABLE. SEVERITY: SERIOUS. RISK: MINIMAL RESIDUAL RISK. CAPA REQUIRED: NO.

    Description of Event or Problem · 1

    AFTER PUTTING THE DENTAL CLAMP ON TOOTH THE CLAMP POPPED OUT OF MOUTH AND INJURED PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641184 HYGENIC DENTAL CLAMP EEF COLTENE WHALEDENT INC. H01049

    Patients

    Seq Age Sex Outcome Treatment
    1