MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-11-11 for HAWLEY RETAINER manufactured by Allesee Orthodontic Appliances.
[21024241]
On (b)(6), 2011, while a patient was sleeping, he managed to remove the hawley retainer and it bacame lodged in the patient's throat.
Patient Sequence No: 1, Text Type: D, B5
[21233864]
The original device was made correctly, and doctor recommended a change in clasping to improve retention. The original device was modified with different clasps that offer more retention. The patient is fine and was advised not to wear the appliance during sleep.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2184045-2011-00009 |
| MDR Report Key | 2333988 |
| Report Source | 05 |
| Date Received | 2011-11-11 |
| Date of Report | 2011-10-10 |
| Date of Event | 2011-10-10 |
| Date Mfgr Received | 2011-10-10 |
| Date Added to Maude | 2011-11-14 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. ORLANDO TADEO, JR. |
| Manufacturer Street | 1717 W COLLINS AVE |
| Manufacturer City | ORANGE CA 92867 |
| Manufacturer Country | US |
| Manufacturer Postal | 92867 |
| Manufacturer Phone | 7145167419 |
| Manufacturer G1 | ALLESEE ORTHODONTIC APPLIANCES |
| Manufacturer Street | 13931 SPRING STREET |
| Manufacturer City | STURTEVANT WI 53177 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53177 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HAWLEY RETAINER |
| Generic Name | HAWLEY RETAINER SERIES |
| Product Code | DYJ |
| Date Received | 2011-11-11 |
| ID Number | WORK ORDER #3440029 |
| Operator | DENTIST |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALLESEE ORTHODONTIC APPLIANCES |
| Manufacturer Address | 13931 SPRING STREET STURTEVANT WI 53177 US 53177 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2011-11-11 |