BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELUXE MODEL B HOT BEAD STERILIZER

    MDR report key: 11659219 · Received April 13, 2021

    Report

    Report Number
    2511556-2021-00004
    Event Type
    Injury
    Date Received
    April 13, 2021
    Date of Event
    March 22, 2021
    Report Date
    April 8, 2021
    Manufacturer
    PREMIER DENTAL PRODUCTS COMPANY
    Product Code
    ETF
    Removal / Correction Number
    REPORTED IN 2001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO COMPONENT FAILURE AND/OR INCORRECT INSTALLATION OF THE THERMOSTAT, AROUND 2001/2002, THERE WAS A RASH OF FAILURES IN WHICH THE HBS(HOT BEAD STERILIZER) UNITS LOST THE ABILITY TO CONTROL ITS OPERATING TEMPERATURE. THE UNITS REACHED TEMPERATURES THAT CAUSED THE PLASTIC HOUSING TO MELT. THIS CAUSED A RECALL AND EVALUATION BY THE FDA OF THE MERITS OF HOT BEAD STERILIZATION. THE APPROVED USE OF THE HOT BEAD STERILIZER WAS TO IMMERSE THE WORKING END OF AN INSTRUMENT INTO THE GLASS BEADS (425°F FOR 5 SECONDS) AND CONSIDERED STERILE' FOR USE ON A PATIENT. THE HOT BEAD STERILIZER WAS NOT USED AS INTENDED AS THE DOCTOR USED IT TO WARM THE MIRROR WITHOUT FIRST COOLING PRIOR TO USE ON THE PATIENT. AT THIS TIME,PREMIER MADE THE DECISION TO DISCONTINUE THE HBS UNITS AND PART OF THE RECALL ACTION, NOTIFICATIONS WERE MADE TO OUR DISTRIBUTORS, CUSTOMERS AND IN INDUSTRY PUBLICATIONS STATING THE HBS WAS UNDER RECALL AND BEING DISCONTINUED. DURING THE RECALL ACTION AND AFTERWARDS, THERE WERE SEVERAL COMPLAINTS OF FAILURES FOR HBS IN CONTINUED USE. DURING PREMIER'S UPDATES ON THE RECALL ACTION, THE FDA RECALL COORDINATOR WAS MADE AWARE OF THESE INSTANCES. THE FDA FELT PREMIER TOOK THE PROPER STEPS OF NOTIFYING CUSTOMERS OF THE SITUATION AND EVENTUALLY CLOSED OUT THE RECALL. HOWEVER, THERE WERE CUSTOMERS WHO DECLINED TO RETURN THEIR UNITS. IN TERMS OF ASSESSING THIS PARTICULAR COMPLAINT, THE CLINIC IS USING A RECALLED PRODUCT UNDER OFF-LABEL CONDITIONS, WHICH WAS DISCONTINUED 20 YEARS AGO.

    Description of Event or Problem · 1

    PATIENT WAS BURNED DURING AN EXAM WITH A LARYNGEAL MIRROR. BIO-MED TECH SAID THAT THE PHYSICIAN INSERTED THE MIRROR INTO THE BEADS FOR A SECOND THEN INSERTED THE MIRROR INTO THE PATIENT'S MOUTH, WITHOUT COOLING THE MIRROR DOWN FIRST. THE TEMPERATURE OF THE BEADS WAS MEASURED AT 320 CELSIUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559010 DELUXE MODEL B HOT BEAD STERILIZER MIRROR WARMER ETF PREMIER DENTAL PRODUCTS COMPANY MODEL B 0377

    Patients

    Seq Age Sex Outcome Treatment
    1 Other