BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASTRON CLEAR SPLINTS

    MDR report key: 10021886 · Received May 4, 2020

    Report

    Report Number
    3011649314-2020-00529
    Event Type
    Injury
    Date Received
    May 4, 2020
    Report Date
    September 24, 2020
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    MQC
    PMA / PMN Number
    K111828
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE INVESTIGATION HAS BEEN COMPLETED AND THE RESULTS ARE AS FOLLOWS: DHR RESULTS: NO DHR WAS AVAILABLE FOR REVIEW. THE DEVICE WAS FABRICATED PER PHYSICIAN'S PRESCRIPTION ONLY. STOCK PRODUCT REVIEWED RESULTS: NO STOCK PRODUCT WAS AVAILABLE FOR REVIEW SINCE THE DEVICE WAS FABRICATED PER PHYSICIAN'S PRESCRIPTION ONLY. INVESTIGATION METHODS/RESULTS: THE RETURNED PARTS INCLUDED AN UPPER TRAY IN AN ORIGINAL CASE. THE DEVICE WAS VISUALLY INSPECTED AND THE RESULTS WERE SUMMARIZED BELOW. PLEASE ALSO SEE ATTACHED PICTURES. ROUGHNESS - THE EDGE WAS SMOOTH. CRACK - NO MAJOR CRACKS WERE FOUND. DELAMINATION - LAYERS WERE INTACT AND DID NOT SEPARATED. DISCOLORATION - NO DISCOLORATION WAS OBSERVED. GENERAL CLEANLINESS - THE DEVICE WAS CLEAN. CASE WAS RETURNED IN A GOOD CONDITION WITH LABEL. ROOT CAUSE: THE ROOT CAUSE CANNOT BE EXPLICITLY DETERMINED. CUSTOMER PROVIDED VERY LIMITED INFORMATION FOR THIS COMPLAINT. PER PREMARKET NOTIFICATION 510(K) SUMMARY FOR CLEARSPLINT (K111828), IT CONTAINED THE FOLLOWING STATEMENT IN PROPOSED INSTRUCTION, "CAUTION: AN ALLERGY TEST IS RECOMMENDED PRIOR TO PLACING (APPLIANCE) IN A DENTAL CAVITY." IT WAS REPORTED THE PATIENT WAS ALLERGY TESTED PRIOR TO THE DEVICE WAS PRESCRIBED AND DELIVERED. PER PROPOSED INSTRUCTION PROVIDED FROM K111828, ASTRON DENTAL CORPORATION SUGGESTED "BRIEFLY PLACE APPLIANCE IN WARM TAP WATER BEFORE INSERTING IN MOUTH." IN THIS CASE, PATIENT WAS INSTRUCTED TO CLEAN THE DEVICE WITH LUKEWARM WATER. IT ALSO DECLARES THAT THE CLEARSPLINT WAS FOUND TO BE BIOCOMPATIBLE.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED. IF/WHEN THE DEVICE IS RETURNED AN INVESTIGATION WILL BE CARRIED OUT AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE EXACT DATE OF EVENT IS UNKNOWN. THIS SECTION IS NOT APPLICABLE TO THIS DEVICE, WITH THE EXCEPTION OF THE LOT NUMBER. THIS SECTION IS NOT APPLICABLE TO THIS DEVICE, WITH THE EXCEPTION OF THE LOT NUMBER.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT HAD AN ALLERGIC REACTION. THE PATIENT STATES THAT SHE IS NOT SURE OF THE EXACT DATE OF THE REACTION, BUT NOTES THAT IT HAPPENED "TWO NIGHTS AFTER WEARING THE GUARD." THE REACTION OCCURRED "AROUND THE INNER PORTION MY UPPER AND LOWER LIP AND IT WAS AN EXTREME BURNING SENSATION." THE PATIENT STOPPED USING THE DEVICE AFTER FOUR NIGHTS. THE REACTION LASTED TWO WEEKS AFTER THE PATIENT DISCONTINUED USING THE DEVICE. THE PATIENT ALSO STATES THAT SHE USED (B)(6) AND ADVIL FOR THE REACTION. THE PATIENT HAS ALLERGIES TO CARROTS AND POTATOES. THE PATIENT WAS ALLERGY TESTED PRIOR TO THE DELIVERY OF THE DEVICE (OTHER RESULTS UNKNOWN).THE PATIENT HAS NO SIGNIFICANT MEDICAL CONCERNS AT THE TIME OF THE DEVICE USAGE. THERE WERE NO ADJUSTMENTS MADE TO THE DEVICE. THE PATIENT WAS TOLD TO CLEAN THE DEVICE WITH LUKEWARM WATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486154 ASTRON CLEAR SPLINTS ASTRON CLEAR SPLINTS MQC PRISMATIK DENTALCRAFT, INC. 1020079341

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention