BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREATHE EASY SPLINT

    MDR report key: 2931951 · Received January 28, 2013

    Report

    Report Number
    2184045-2013-00002
    Event Type
    Injury
    Date Received
    January 28, 2013
    Report Date
    January 7, 2013
    Manufacturer
    ALLESEE ORTHODONTIC APPLIANCES
    Product Code
    LRK
    PMA / PMN Number
    K070327
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT DISCONTINUED USE OF THE APPLIANCE AND THE DOCTOR PRESCRIBED AN ANTIBIOTIC OINTMENT (BACTROBAN CREAM 2%) FOR TREATMENT. TO DATE, THE PATIENT IS DOING FINE AND HAS FULLY RECOVERED. A NEW APPLIANCE WILL BE FABRICATED FROM A DIFFERENT MATERIAL FOR THE PATIENT.

    Description of Event or Problem · 1

    A DOCTOR'S OFFICE HAD ALLEGED THAT ONE (1) PATIENT HAD EXPERIENCED A POSSIBLE ALLERGIC REACTION TO THE ACRYLIC MATERIAL IN THEIR BREATHE EASY SPLINT APPLIANCE WITH SYMPTOMS OF DRYNESS OF THE MOUTH AND LIPS, WITH CRACKING OF THE LIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38074 BREATHE EASY SPLINT ORTHODONTIC MANDIBULAR REPOSITIONING DEVICE LRK ALLESEE ORTHODONTIC APPLIANCES

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R