BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REST ASSURED, GEN II ORIGINAL

    MDR report key: 4343209 · Received December 18, 2014

    Report

    Report Number
    1825660-2014-00980
    Event Type
    Malfunction
    Date Received
    December 18, 2014
    Date of Event
    November 24, 2014
    Report Date
    December 17, 2014
    Manufacturer
    RANIR, LLC
    Product Code
    OBR
    PMA / PMN Number
    K091792
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONSUMER STATED HE BOUGHT THE GUARD MONTHS AGO AND IS FINALLY USING IT. THE INSTRUCTIONS WERE CLEAR AND HE HAS FITTED THIS TYPE OF GUARD BEFORE. HE HAD TO RE-BOIL THIS ONE AN EXTRA TIME BECAUSE THE INITIAL FIT COOLED BEFORE HE GOT A GOOD IMPRESSION. UPON THE 2ND ATTEMPT, THE FRONT PART OF THE HARD MATERIAL DISINTEGRATED, BUT THE IMPRESSION WAS OK. HE HAD TO TRIM BACK THE ENDS MULTIPLE TIME DUE TO VERY SHARP CORNERS THAT DUG IN WHILE HE SLEPT. AFTER ABOUT 2 WEEKS THE SOFT MATERIAL STARTED TO DETACH FROM THE HARD MATERIAL.

    Description of Event or Problem · 1

    CONSUMER STATED HE BOUGHT THE GUARD MONTHS AGO AND IS FINALLY USING IT. THE INSTRUCTIONS WERE CLEAR AND HE HAS FITTED THIS TYPE OF GUARD BEFORE. HE HAD TO RE-BOIL THIS ONE AN EXTRA TIME BECAUSE THE INITIAL FIT COOLED BEFORE HE GOT A GOOD IMPRESSION. UPON THE 2ND ATTEMPT, THE FRONT PART OF THE HARD MATERIAL DISINTEGRATED, BUT THE IMPRESSION WAS OK. HE HAD TO TRIM BACK THE ENDS MULTIPLE TIME DUE TO VERY SHARP CORNERS THAT DUG IN WHILE HE SLEPT. AFTER ABOUT 2 WEEKS THE SOFT MATERIAL STARTED TO DETACH FROM THE HARD MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833394 REST ASSURED, GEN II ORIGINAL MOUTH GUARD OBR RANIR, LLC REST ASSURED, GEN II ORIGINAL

    Patients

    Seq Age Sex Outcome Treatment
    1