BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOLITE SYSTEM MOUTHPIECE

    MDR report key: 3426510 · Received October 16, 2013

    Report

    Report Number
    2032574-2013-00001
    Event Type
    Injury
    Date Received
    October 16, 2013
    Date of Event
    August 1, 2013
    Report Date
    October 14, 2013
    Manufacturer
    INNERLITE, INC., DBA ISOLITE SYSTEMS
    Product Code
    EAY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT COMPLAINED TO DENTIST OF PAIN IN JAW, 2 WEEKS AFTER DENTAL PROCEDURE (FILLING) USING THE ISOLITE MOUTHPIECE. DENTIST REFERRED PATIENT TO ORAL SURGEON WHO DIAGNOSED PATIENT WITH TMJ (TEMPOROMANDIBULAR JOINT) DISORDER. AT THE TIME, THE PATIENT FILE THE COMPLAINT WITH US (MFR) HE HAD ALMOST FULLY RECOVERED BUT STILL HAD SOME LIMITED MOBILITY OF HIS JAW.

    Description of Event or Problem · 1

    TWO WEEKS AFTER NORMAL DENTAL PROCEDURE TO REPLACE A FILLING, PATIENT EXPERIENCED JAW PAIN AND THE INABILITY TO CLOSE HIS MOUTH (TEMPOROMANDIBULAR JOINT DISORDER, TMJ). HE REPORTED THIS TO THE DENTIST WHO PERFORMED THE DENTAL PROCEDURE AT THAT TIME. THE DENTIST DID NOT NOTIFY US (THE MFR). THE PATIENT NOTIFIED US ON (B)(4) 2013. DENTIST PERFORMED A STANDARD DENTAL PROCEDURE FOR A FILLING IN A TOOTH OF THE PATIENT. THE DOCTOR USED AN ISOLITE SYSTEM AND ISOLITE SYSTEM MOUTHPIECE USED FOR RETRACING THE TONGUE, KEEPING THE MOUTH OPEN WITH THE BITE BLOCK (INTEGRATED INTO THE DESIGN OF THE MOUTHPIECE, UTILIZING THE VACUUM AND ILLUMINATION FEATURES OF THE...

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530532 ISOLITE SYSTEM MOUTHPIECE ISOLITE MOUTHPIECE EAY INNERLITE, INC., DBA ISOLITE SYSTEMS CIL0800

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other