BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPT-IT

    MDR report key: 104030 · Received June 30, 1997

    Report

    Report Number
    104030
    Event Type
    Injury
    Date Received
    June 30, 1997
    Date of Event
    January 6, 1997
    Report Date
    January 8, 1997
    Manufacturer
    WFT/AQUAPLAST CORP.
    Product Code
    BRT
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A MOLD WAS MADE TO OPEN MOUTH AND PUSH TONGUE INTO A CONSISTENT POSITION FOR RADIATION TREATMENT. PRODUCT USED WAS LOW TEMPERATURE PELLET, ADAPT-IT FORM. THE MOLD WOULD NOT RELEASE FROM THE PT'S LOWER TEETH. (UPPER RELEASED) A VACUUM PREVENTED LOWER TEETH FROM RELEASING. DR. TRIED TO RELEASE. AFTER SOMETIME ORAL SURG. WAS CALLED. PT TO OR TO DRILL A HOLE IN THE MOLD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADAPT-IT PELLETS TO FORM RIGID MOLD WHEN DRY BRT WFT/AQUAPLAST CORP. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention NO MEDICATIONS, RADIATION THERAPY NOW STARTED.