BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASTRON CLEAR SPLINTS

    MDR report key: 9484454 · Received December 17, 2019

    Report

    Report Number
    3011649314-2019-00780
    Event Type
    Injury
    Date Received
    December 17, 2019
    Report Date
    April 20, 2020
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    MQC
    PMA / PMN Number
    K111828
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    CORRECTED DATE: THIS INFORMATION WAS OMITTED FROM THE SUPPLEMENTAL FOLLOW-UP #1. THE ACTUAL COMPLAINT DEVICE HAS NOT BEEN RETURNED. HOWEVER, AN 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 ONLY REPORTED PATIENT HAD NO KNOWN ALLERGIES. 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 DEVICE HAS NOT YET BEEN RETURNED. AN INVESTIGATION WILL BE CONDUCTED ONCE THE SAMPLE HAS BEEN RETURNED AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    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, THE PATIENT EXPERIENCED SWELLING OF THE LIPS ON UNKNOWN DATE. IT IS UNKNOWN WHETHER OR NOT THE PATIENT HAS ANY KNOWN ALLERGIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1276513 ASTRON CLEAR SPLINTS ASTRON CLEAR SPLINTS MQC PRISMATIK DENTALCRAFT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention