BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASTRON CLEAR SPLINT LOWER

    MDR report key: 9646774 · Received January 30, 2020

    Report

    Report Number
    3011649314-2020-00444
    Event Type
    Injury
    Date Received
    January 30, 2020
    Date of Event
    October 23, 2019
    Report Date
    April 24, 2020
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    MQC
    PMA / PMN Number
    K111828
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED. HOWEVER, 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. 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." HOWEVER, IT WAS UNKNOWN IF ANY DENTAL OR MEDICAL HISTORY WAS PROVIDED BY THE PATIENT PRIOR TO THE DEVICE WAS PRESCRIBED. IN ADDITION, IT WAS UNKNOWN HOW PATIENT WAS INSTRUCTED TO MAINTAIN AND CLEAN THE DEVICE. 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 PATIENTS WEIGHT IS NOT PROVIDED AS IT IS NOT TAKEN AT THE TIME OF THE APPOINTMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A POSSIBLE ALLERGIC REACTION. THE LOCAL NOTED IS "INTRA-ORAL." THE PATIENT WAS REPORTED TO HAVE "BUMPS DEVELOPING IN THE MOUTH AROUND TONGUE AND CHEEKS WHERE NIGHT GUARD CAME INTO CONTACT." THE PATIENT STARTED FEELING "WEIRD" ON THE FIRST DAY OF USE, WHICH HE BELIEVES WAS (B)(6) 2019. HIS TONGUE BEGAN TO ITCH, BUT HE WORE IT FOR A FEW NIGHTS (3-4 NIGHTS). HE THEN DISCONTINUED USE OF THE DEVICE." HE DID NOT SEEK MEDICAL INTERVENTION. HE FURTHER EXPLAINS THAT HIS NOSE WAS INCREASINGLY STUFFY. THE PATIENT RETURNED ON (B)(6) 2019 FOR NEW IMPRESSIONS AND A RE-MAKE USING DIFFERENT MATERIAL. THE PATIENT WAS ALLERGY TESTED. HE HAS NO KNOWN ALLERGIES, EXCEPT FOR POLLEN AND DUST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113119 ASTRON CLEAR SPLINT LOWER ASTRON CLEAR SPLINT MQC PRISMATIK DENTALCRAFT, INC. 1105335385

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR