MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-10-03 for MANDIUBLAR ANTERIOR REPOSITIONING APPLIANCE (MARA) manufactured by Allesee Orthodontic Appliances.
[19177367]
In 2008, a doctor reported that a patient developed cheek ulcers due to irritation from wearing the mara appliance and needed shorther buccal shields.
Patient Sequence No: 1, Text Type: D, B5
[19339505]
Since each appliance is custom made to the request of the prescription there was no product problem. The doctor has requested that the appliance's buccal shields be changed to smaller shields for patient comfort. The nature of the product was irritating the patient's cheek. The doctor prescribed amoxycillin antibiotic to help heal the cheek irritation and the appliance was removed. The patient's ulcers have now completely healed. The patient will be fitted with the modified appliance with shorter buccal shields at his next appointment. This is the final report. No device problem
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2184045-2008-00002 |
| MDR Report Key | 1183188 |
| Report Source | 05 |
| Date Received | 2008-10-03 |
| Date of Report | 2008-09-05 |
| Date Mfgr Received | 2008-09-05 |
| Device Manufacturer Date | 2008-06-19 |
| Date Added to Maude | 2008-10-03 |
| 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 | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MANDIUBLAR ANTERIOR REPOSITIONING APPLIANCE (MARA) |
| Generic Name | POSITIONER, TOOTH, PREFORMED |
| Product Code | KMY |
| Date Received | 2008-10-03 |
| Returned To Mfg | 2008-09-05 |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1213936 |
| Manufacturer | ALLESEE ORTHODONTIC APPLIANCES |
| Manufacturer Address | 13931 SPRING STREET STURTEVANT WI 53177 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-10-03 |