BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOFORM RETAINER

    MDR report key: 16522007 · Received March 10, 2023

    Report

    Report Number
    3011649314-2023-00135
    Event Type
    Injury
    Date Received
    March 10, 2023
    Report Date
    March 10, 2023
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    DYJ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN RETURNED. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DEVICE IS MANUFACTURED BY PRESCRIPTION. THE DEVICE IS MANUFACTURED BY PRESCRIPTION AND NOT IMPLANTABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A REACTION TO THE THERMOFORM RETAINER THAT WAS ISSUED. IT IS UNCLEAR WHEN THE PATIENT RECEIVED THE DEVICE, WHEN THE PATIENT FIRST USED THE DEVICE, OR WHEN THE REACTION OCCURRED OR RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1141728 THERMOFORM RETAINER THERMOFORM RETAINER DYJ PRISMATIK DENTALCRAFT, INC. 1120587206

    Patients

    Seq Age Sex Outcome Treatment
    1 Female