BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTABLE CLASS III MASK

    MDR report key: 2236816 · Received August 30, 2011

    Report

    Report Number
    1316408-2011-00001
    Event Type
    Injury
    Date Received
    August 30, 2011
    Date of Event
    July 27, 2011
    Report Date
    August 1, 2011
    Manufacturer
    GREAT LAKES ORTHODONTICS LTD
    Product Code
    DZB
    PMA / PMN Number
    K861424
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON DISCUSSION OF EVENT WITH THE ORTHODONTIST WHO PRESCRIBED AND DELIVERED THE MASK TO THE PT, THE MASK WAS NOT A PROBLEM. HE HAS BEEN USING THIS MASK FOR MANY YEARS AND FEELS CONFIDENT IN THE USE OF THE PRODUCT. THE DOCTOR WAS GOING TO SPEAK WITH THE PARENT AND UPDATE GREAT LAKES ON ANY FURTHER INFO. AS OF THE DATE OF THIS REPORT NO FURTHER INFO HAS BEEN RECEIVED FROM THE ORTHODONTIST. MASK RECEIVED BACK FROM PARENT ON (B)(6) 2011. MASK IS IN GOOD ORDER AND MEETS SPECIFICATIONS.

    Description of Event or Problem · 1

    COPIED AND PASTED FROM THE EMAIL NOTIFICATION RECEIVED FROM PARENT: MY SON HAS AN UNDERBITE DUE TO UNDERDEVELOPMENT OF THE MAXILLA. HE HAS BEEN UNDERGOING ORTHODONTIC CARE TO REPAIR THIS COMMON CONDITION. INITIALLY THIS WAS WITH A RETAINER TYPE EXPANDER. ON (B)(6) 2011 (TWO DAYS BEFORE THE EVENT) OUR ORTHODONTIST STARTED A NEW COURSE OF TREATMENT WHICH INVOLVED USING A CEMENTED EXPANDER ATTACHED TO UPPER MOLARS, WITH HOOKS TO ATTACH IT TO EXTERNAL HEAD GEAR VIA RUBBER BANDS. WE WERE INSTRUCTED THAT HE DID NOT HAVE TO WEAR THIS AT SCHOOL, BUT HE SHOULD WEAR THIS WHILE HE IS HOME, INCLUDING SLEEPING WITH THE HEAD GEAR ON. THE HEAD GEAR IN QUESTION IS THE "ADAPTABLE CLASS III MASK -(B)(6) ". MY SON SLEPT THE FIRST NIGHT WEARING THIS DEVICE, WITHOUT APPARENT INCIDENT. ON THE SECOND NIGHT WEARING THIS DEVICE, HE STOPPED BREATHING WHILE SLEEPING, SUFFERED A SEIZURE, AND DID NOT RESUME BREATHING UNTIL AFTER I REMOVED THE DEVICE. HE HAD A CLASSIC POST ICTAL COURSE (POST SEIZURE SOMNOLENCE, LACK OF RESPONSIVENESS, LOSS OF MEMORY) OF THE EVENT) THAT LASTED SEVERAL HOURS, INCLUDING EVALUATION BY PARAMEDICS, AMBULANCE TRANSPORT, AND OBSERVATION IN THE EMERGENCY DEPARTMENT FOR SIX HOURS. MY WIFE AND I ARE BOTH PHYSICIANS, AND TRAINED MEDICAL OBSERVERS. WE ARE QUITE FORTUNATE THAT WE WERE NEARBY AND WERE ABLE TO NOTICE THE SEIZURE QUICKLY, AND REMOVE THE DEVICE, AND OPEN HIS AIRWAY PROMPTLY. THE HEAD GEAR IN QUESTION HAS A CUP WHICH RESTS ON THE PTS JAW. THERE IS A FLAT FOREHEAD REST THAT ATTACHES TO THE FOREHEAD. BETWEEN THE TWO THERE IS A METAL FRAME, WHERE RUBBER BANDS ATTACH THE CEMENTED EXPANDER FROM THE MAXILLA TO THE HEAD GEAR. THIS FIRMLY THEN ATTACHES THE HEAD GEAR TO THE CHILD'S FACE. THE PROBLEM WITH THE DEVICE IS THAT IT RESTRICTS JAW MOVEMENT. CHILDREN OFTEN ARE MOUTH BREATHERS, AND ANY RESTRICTION IN JAW MOVEMENT IN SLEEP, PARTICULARLY COUPLED WITH DIFFICULTY SWALLOWING SECRETIONS DUE TO THE CEMENTED EXPANDER IN THE MOUTH, CAN LEAD A CHILD TO CHOKE, OR SIMPLY NOT BE ABLE TO INHALE. THIS IS WHAT HAPPENED TO OUR SON. WE ARE FORTUNATE THAT HE APPEARS TO HAVE MADE A COMPLETE RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADAPTABLE CLASS III MASK EXTRA ORAL HEADGEAR DZB GREAT LAKES ORTHODONTICS LTD H114 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Other| R