BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASTRON CLEAR SPLINTS

    MDR report key: 9075605 · Received September 17, 2019

    Report

    Report Number
    3011649314-2019-00537
    Event Type
    Injury
    Date Received
    September 17, 2019
    Report Date
    January 31, 2020
    Manufacturer
    PRISMATIK DENTALCRAFT INC.
    Product Code
    MQC
    PMA / PMN Number
    K111828
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, NO INVESTIGATIONS COULD BE CONDUCTED.

    Additional Manufacturer Narrative · 0

    CORRECTED: THIS INFORMATION WAS OMITTED AT THE TIME OF THE SUPPLEMENTAL REPORT FOLLOW UP #1. THE DEVICE INVESTIGATION HAS BEEN COMPLETED AND THE RESULTS ARE AS FOLLOWS: DEVICE HISTORY RECORD: NO DHR WAS AVAILABLE FOR REVIEW. THE DEVICE WAS FABRICATED PER PHYSICIAN'S PRESCRIPTION ONLY. RETURNED SAMPLE: 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 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. THIS COMPLAINT WILL BE KEPT ON RECORD FOR TRACK AND TRENDING PURPOSES.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED. AN INVESTIGATION WILL BE COMPLETED ONCE THE SAMPLE HAS BEEN RETURNED AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED. MODEL NUMBER - NOT APPLICABLE, CATALOG NUMBER - NOT APPLICABLE, LOT NUMBER - NOT APPLICABLE, EXPIRATION DATE - NOT APPLICABLE, UDI NUMBER - NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED AN ALLERGIC REACTION AFTER USING AN ASTRON CLEAR SPLINT (UPPER) DEVICE. ACCORDING TO THE INFORMATION PROVIDED BY THE DOCTOR VIA E-MAIL, THE PATIENT EXPERIENCED SWELLING OF THE LIPS SHORTLY AFTER THE DELIVERY OF THE DEVICE (DATE UNKNOWN). IT IS UNKNOWN WHETHER OR NOT THE PATIENT HAS ANY KNOWN ALLERGIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    871771 ASTRON CLEAR SPLINTS ASTRON CLEAR SPLINTS MQC PRISMATIK DENTALCRAFT INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention