MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-06-14 for MANDIBULAR ANTERIOR REPOSITIONING APPLIANCE (MARA) manufactured by Allesee Orthodontic Appliances.
[47396649]
Doctor alleged that the upper left crown split and the patient swallowed it. To date the patient is fine and waiting for the component to pass naturally.
Patient Sequence No: 1, Text Type: N, H10
[47396650]
It was alleged by the doctor that the patient swallowed the crown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2184045-2016-00002 |
| MDR Report Key | 5724850 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-06-14 |
| Date of Report | 2016-05-17 |
| Date Mfgr Received | 2016-05-17 |
| Date Added to Maude | 2016-06-14 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. MARI LAMBERT |
| Manufacturer Street | 13931 SPRING STREET |
| Manufacturer City | STURTEVANT WI 53177 |
| Manufacturer Country | US |
| Manufacturer Postal | 53177 |
| Manufacturer Phone | 2623213670 |
| 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 | MANDIBULAR ANTERIOR REPOSITIONING APPLIANCE (MARA) |
| Generic Name | POSITIONER, TOOTH PREFORMED |
| Product Code | KMY |
| Date Received | 2016-06-14 |
| 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. Other | 2016-06-14 |