MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-03-03 for MANDIBULAR ANTERIOR REPOSITIONING APPLIANCE (MARA) manufactured by Allesee Orthodontic Appliances.
[21427514]
On february 4, 2010, a doctor reported that a patient developed severe mouth sores due to irritation from wearing the mara appliance and needed to take antibiotics for infection.
Patient Sequence No: 1, Text Type: D, B5
[21433030]
Since each appliance is custom made to the request of the prescription there was no product problem. The doctor has requested that a new appliance be fabricated of a different design for the patient's comfort. The product was irritating the patient's cheek, causing severe sores and an infection. The doctor prescribed antibiotics to treat the infection. The patient is doing fine and will be fitted with the new appliance. This is the final report. Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2184045-2010-00001 |
| MDR Report Key | 1621490 |
| Report Source | 05 |
| Date Received | 2010-03-03 |
| Date of Report | 2010-02-04 |
| Date Mfgr Received | 2010-02-04 |
| Device Manufacturer Date | 2009-11-13 |
| Date Added to Maude | 2010-03-04 |
| 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 | MANDIBULAR ANTERIOR REPOSITIONING APPLIANCE (MARA) |
| Generic Name | POSITIONER, TOOTH, PREFORMED |
| Product Code | KMY |
| Date Received | 2010-03-03 |
| ID Number | WO3045921/3094404 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2010-03-03 |