ADAPTABLE CLASS III MASK H114

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-07-31 for ADAPTABLE CLASS III MASK H114 manufactured by Great Lakes Orthodontics, Ltd..

Event Text Entries

[2131425] 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 headgear 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 - dr (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 eval 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 headgear in question has a cup which rests on the pt's 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 headgear. This firmly then attaches the headgear 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5021564
• MDR Report Key: 2190630
• Date Received: 2011-07-31
• Date of Report: 2011-07-31
• Date of Event: 2011-07-29
• Date Added to Maude: 2011-08-04
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT FAMILY MEMBER OR FRIEND
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ADAPTABLE CLASS III MASK
• Generic Name: ORTHODONTIC HEADGEAR STD SIZE
• Product Code: DZB
• Date Received: 2011-07-31
• Model Number: H114
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: GREAT LAKES ORTHODONTICS, LTD.
• Manufacturer Address: 200 COOPER AVE P.O. BOX 5111 TONAWANDA NY 14151511 US 14151 5111

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Life Threatening; 3. Other; 4. Deathisabilit	2011-07-31