BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMPLE PREP CARBIDE

    MDR report key: 13446441 · Received February 3, 2022

    Report

    Report Number
    2416455-2022-00001
    Event Type
    Injury
    Date Received
    February 3, 2022
    Date of Event
    January 1, 2022
    Report Date
    April 21, 2022
    Manufacturer
    COLTENE WHALEDENT INC.
    Product Code
    EJL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: (B)(4) UNITS OF THIS KIT WERE PUT TO STOCK IN SEPTEMBER 2021. THERE ARE NO UNITS REMAINING. COMPLAINT ANALYSIS FOR THE LAST 12 MONTHS IDENTIFIES NO ADDITIONAL COMPLAINTS FOR THIS PRODUCT. NO PRODUCT HAS BEEN RETURNED FOR INVESTIGATION. THESE KITS WERE PACKAGED WITH SEMI-FINISHED BURS 50008508 K91987. THIS BATCH RECORD WAS REVIEWED. ALL DIMENSIONAL REQUIREMENTS AND THE FUNCTIONAL TEST FOR NECK STRENGTH WERE MET. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. ROOT CAUSE: NO TRUE ROOT CAUSE COULD BE IDENTIFIED IN THIS COMPLAINT. POSSIBLE ROOT CAUSES INCLUDE: THE BURS MAY HAVE BEEN DAMAGED UPON ARRIVAL TO THE CUSTOMER BUT THE CUSTOMER MAY NOT HAVE NOTICED PRIOR TO USING THE PRODUCT. THE BURS MAY HAVE BEEN USED MULTIPLE TIMES AND THE FLUTE EDGES MAY HAVE BEEN WORN. USING A BUR WITH EXCESSIVE WEAR MAY CAUSE THE BUR TO BREAK OR CAUSE INJURY. COLD DISINFECTANT SOLUTIONS MAY HAVE BEEN USED THAT CONTAIN CORROSIVE AGENTS THAT DEGRADE THE PERFORMANCE AND STRENGTH OF THE CARBIDE BURS. THE BURS MAY NOT HAVE BEEN STORED IN A MOISTURE FREE ENVIRONMENT. THE BURS MAY HAVE BEEN USED WITH HEAVY TRANSVERSE CUTTING PRESSURE.

    Description of Event or Problem · 0

    BUR HEAD BREAKS OFF. BUR BROKE WHILE USING ON PATIENT. DOCTOR COULD NOT FIND BROKEN TIP PATIENT WAS SENT TO HAVE XRAYS TO MAKE SURE TIP WAS NOT SWALLOWED. NO SURGICAL INTERVENTION WAS REQUIRED. ON (B)(6) 2022 ADDITIONAL INFORMATION WAS PROVIDED: FEMALE (B)(6). CHEST X-RAY FOUND NOTHING. DOCTOR SAID THAT HE THINKS THEY FOUND THE BROKEN TIP BUT WAS NOT FOR SURE. THIS IS WHY THEY DID CHEST X-RAY FOR PATIENT SAFETY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1451216 SIMPLE PREP CARBIDE CARBIDE BUR EJL COLTENE WHALEDENT INC. K99739

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female Required Intervention