MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2011-08-30 for ADAPTABLE CLASS III MASK H114 HST manufactured by Great Lakes Orthodontics Ltd.
[16723750]
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.
Patient Sequence No: 1, Text Type: D, B5
[17045719]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1316408-2011-00001 |
| MDR Report Key | 2236816 |
| Report Source | 04 |
| Date Received | 2011-08-30 |
| Date of Report | 2011-08-01 |
| Date of Event | 2011-07-27 |
| Date Mfgr Received | 2011-08-01 |
| Date Added to Maude | 2011-09-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | DAVE GRAVER, QUALITY MGR |
| Manufacturer Street | 200 COOPER AVE |
| Manufacturer City | TONAWANDA NY 14150 |
| Manufacturer Country | US |
| Manufacturer Postal | 14150 |
| Manufacturer Phone | 7163191250 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADAPTABLE CLASS III MASK |
| Generic Name | EXTRA ORAL HEADGEAR |
| Product Code | DZB |
| Date Received | 2011-08-30 |
| Returned To Mfg | 2011-08-30 |
| Model Number | H114 |
| Catalog Number | HST |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GREAT LAKES ORTHODONTICS LTD |
| Manufacturer Address | TONAWANDA NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2011-08-30 |