BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NARVAL CC ORTHESE MRD

    MDR report key: 4039863 · Received July 30, 2014

    Report

    Report Number
    3004604967-2014-00018
    Event Type
    Injury
    Date Received
    July 30, 2014
    Manufacturer
    RESMED SAS
    Product Code
    LQZ
    PMA / PMN Number
    K113201
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THE DENTIST RETURNED THE DEVICE AND THE ORIGINAL MODELS OF THE PT'S TEETH. THE RETURNED DEVICE FIT THE ORIGINAL TEETH MODEL THAT WAS USED TO FABRICATE THE DEVICE. THE INFO PROVIDED BY THE REPORTER INDICATES THAT THE PT HAD AN EXISTING DENTAL CONDITION. THIS CONDITION MAY HAVE BEEN EXACERBATED BY THE USE OF THE MANDIBULAR DEVICE AND LED TO THE PT'S TOOTH REMOVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED RMT THAT THE NARVAL CC MANDIBULAR REPOSITIONING DEVICE CONTRIBUTED TO A TOOTH LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445882 NARVAL CC ORTHESE MRD LQZ RESMED SAS

    Patients

    Seq Age Sex Outcome Treatment
    1