MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-02-27 for POSITIONER manufactured by Allesee Orthodontic Appliances.
[5476095]
A doctor alleged that a patient had experienced an allergic reaction with symptoms of swelling, redness and oozing on the outside of the mouth, cheeks and face after placement with of the positioner.
Patient Sequence No: 1, Text Type: D, B5
[13017518]
Patient specifics with regard to age and weight was not provided. It was reported that the patient sought medical attention with an allergist where she was prescribed antibiotics and steroids. She was diagnosed with an allergic reaction to vinyl material. The appliance was removed. To date, the patient has fully recovered and is doing fine.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2184045-2015-00003 |
| MDR Report Key | 4554375 |
| Report Source | 05 |
| Date Received | 2015-02-27 |
| Date of Report | 2015-02-11 |
| Date Mfgr Received | 2014-02-11 |
| Date Added to Maude | 2015-02-27 |
| 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 | MS. KERRI CASINO |
| Manufacturer Street | 1717 W. COLLINS AVE. |
| Manufacturer City | ORANGE CA 92867 |
| Manufacturer Country | US |
| Manufacturer Postal | 92867 |
| Manufacturer Phone | 7145167634 |
| 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 | POSITIONER |
| Generic Name | PERFORMED TOOTH POSITIONER |
| Product Code | KMY |
| Date Received | 2015-02-27 |
| ID Number | WO # 7750203 |
| Operator | OTHER |
| Device Eval'ed by Mfgr | Y |
| 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. Hospitalization; 2. Other | 2015-02-27 |