MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-08-28 for MARA manufactured by Aoa.
| Report Number | 2184045-2019-00003 |
| MDR Report Key | 8941269 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-08-28 |
| Date of Report | 2019-08-28 |
| Date of Event | 2019-08-07 |
| Date Mfgr Received | 2019-08-07 |
| Device Manufacturer Date | 2019-07-30 |
| Date Added to Maude | 2019-08-28 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. SUZANNE SIMPKINS |
| Manufacturer Street | 13931 SPRING STREET |
| Manufacturer City | STURTEVANT WI 53177 |
| Manufacturer Country | US |
| Manufacturer Postal | 53177 |
| Manufacturer Phone | 2628861050 |
| 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 | MARA |
| Generic Name | MANDIBULAR ANTERIOR REPOSITIONING APPLIANCE |
| Product Code | EJF |
| Date Received | 2019-08-28 |
| Lot Number | 4693229 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AOA |
| Manufacturer Address | 13931 SPRING STREET STURTEVANT WI 53177 US 53177 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-08-28 |