MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-09-09 for TWIN BLOCK manufactured by Allesee Orthodontic Appliances.
[1226843]
Patient swallowed a lower twin block appliance which became stuck in the paratonsillar area.
Patient Sequence No: 1, Text Type: D, B5
[8413766]
The twin block appliance is a removable device. When the patient swallowed the appliance, she was taken to the hospital where the appliance was surgically removed via an outpatient procedure. The patient was not admitted to the hospital. The patient is doing fine and a different appliance will be placed. This incident is being reported because medical intervention was required to preclude a serious injury.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2184045-2009-00001 |
| MDR Report Key | 1465223 |
| Report Source | 05 |
| Date Received | 2009-09-09 |
| Date of Report | 2009-08-14 |
| Date Mfgr Received | 2009-08-14 |
| Device Manufacturer Date | 2009-04-17 |
| Date Added to Maude | 2009-09-10 |
| 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 | 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 | TWIN BLOCK |
| Generic Name | PREFORMED TOOTH POSITIONER |
| Product Code | KMY |
| Date Received | 2009-09-09 |
| ID Number | WO 2993359 |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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. Required No Informationntervention | 2009-09-09 |