MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-08-09 for MANDIBULAR ANTERIOR REPOSITIONING APPLIANCE (MARA) manufactured by Allesee Orthodontic Appliances.
[1627961]
On (b)(6) 2010, a doctor reported that a patient developed a sore in her mouth, due to irritaion caused by the mara appliance.
Patient Sequence No: 1, Text Type: D, B5
[8677623]
The doctor stated that amoxicillin was prescribed to treat the infection that resulted from a sore caused by the mara appliance. The sore has healed completely and the patient is doing fine. The appliance was not returned for evaluation. A new appliance is being made and will be placed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2184045-2010-00004 |
| MDR Report Key | 1789800 |
| Report Source | 05 |
| Date Received | 2010-08-09 |
| Date of Report | 2010-07-09 |
| Date Mfgr Received | 2010-07-09 |
| Date Added to Maude | 2010-08-10 |
| 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 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 | MANDIBULAR ANTERIOR REPOSITIONING APPLIANCE (MARA) |
| Generic Name | POSITIONER, TOOTH, PREFORMED |
| Product Code | KMY |
| Date Received | 2010-08-09 |
| ID Number | WO3183929 |
| 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 | 2010-08-09 |