BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASTRON CLEAR SPLINT

    MDR report key: 10311499 · Received July 22, 2020

    Report

    Report Number
    3011649314-2020-00593
    Event Type
    Injury
    Date Received
    July 22, 2020
    Date of Event
    June 25, 2020
    Report Date
    October 28, 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 DEVICE WAS NOT RETURNED FOR INVESTIGATION. THE PATIENT CONTINUED TO WEAR THE DEVICE. ROOT CAUSE: THE ROOT CAUSE CANNOT BE EXPLICITLY DETERMINED. 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. "HOWEVER, IT WAS REPORTED THAT THE PATIENT HAS NO KNOWN ALLERGIES. THERE WAS NO ALLERGY TEST DONE PRIOR TO USING THE DEVICE PLACING APPLIANCE IN A DENTAL CAVITY." THE PATIENT WAS INSTRUCTED TO CLEAN AND MAINTAIN THE DEVICE WITH TOOTHPASTE AND TOOTHBRUSH. PER PROPOSED INSTRUCTION PROVIDED FROM K111828, ASTRON DENTAL CORPORATION SUGGESTED "BRIEFLY PLACE APPLIANCE IN WARM TAP WATER BEFORE INSERTING IN MOUTH." PER SUPPLEMENT DATA FROM K111828, 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. IS NOT APPLICABLE WITH THE EXCEPTION OF LOT NUMBER AS THE DEVICE IS MANUFACTURED BY PRESCRIPTION. IS NOT APPLICABLE AS THE DEVICE IS MANUFACTURED BY PRESCRIPTION NOT IMPLANTABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN ALLERGIC REACTION TO THE ASTRON DEVICE. THE REACTION OCCURRED "ITCHING/BURNING SENSATION ON TONGUE." THE REACTION OCCURRED SHORTLY AFTER USE. THE DEVICE WAS FIRST USED ON 6-25-20 WITH AN INITIAL REACTION THE FIRST DAY OF USAGE. THE PATIENT DID NOT REQUIRE MEDICAL TREATMENT AND CONTINUES TO USE THE DEVICE. IT IS REPORTED THAT THE PATIENT HAS NO KNOWN ALLERGIES. THERE WAS NO ALLERGY TEST DONE PRIOR TO USING THE DEVICE. WITH REGARD TO THE DEVICE: PRIOR TO THE DELIVERY OF THE DEVICE, IT WAS "SANITIZED WITH OUR ANTIBACTERIAL HAND SOAP (SOFT SOAP BRAND)THE PATIENT WAS INSTRUCTED TO CLEAN THE DEVICE WITH SENSODYNE TOOTH PASTE AND A SOFT TOOTHBRUSH. THE DEVICE WILL NOT BE RETURNED. THE PATIENT CONTINUES TO WEAR THE DEVICE NIGHTLY. THE PATIENT HAS A HISTORY OF GERD, HYPOTHYROIDISM, ALZHEIMER'S, HYPERCHOLESTEROLEMIA, DIABETES AND ARTHRITIS. CURRENT MEDICATIONS INCLUDE: PROPRUNOLOL, MEMATINE, PEPCID, PROTONIX,LIPITOR, METFORMIN,LEVOTHYROXINE, LACTULOSE, AMIVIG, AND FLONASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772224 ASTRON CLEAR SPLINT ASTRON CLEAR SPLINT MQC PRISMATIK DENTALCRAFT, INC. 1106895796

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR