MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-09-07 for RAPID PALATAL EXPANDER manufactured by Allesee Orthodontic Appliances.
[85161565]
The doctor alleged the patient experienced an allergic reaction to the appliance. In a telephone conversation with the doctor, the patient has an allergy to nickel which was not conveyed to the doctor prior to treatment with the rpe. The appliance was removed and the patient is fine.
Patient Sequence No: 1, Text Type: N, H10
[85161566]
Doctor alleged the patient experienced an allergic reaction to the rapid palatal expander.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2184045-2017-00002 |
| MDR Report Key | 6849369 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-09-07 |
| Date of Report | 2017-08-08 |
| Date of Event | 2017-08-08 |
| Date Mfgr Received | 2017-08-08 |
| Device Manufacturer Date | 2017-07-26 |
| Date Added to Maude | 2017-09-07 |
| 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 | MRS. MARI LAMBERT |
| Manufacturer Street | 13931 SPRING STREET |
| Manufacturer City | STURTEVANT WI 53177 |
| Manufacturer Country | US |
| Manufacturer Postal | 53177 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RAPID PALATAL EXPANDER |
| Generic Name | RPE |
| Product Code | DYJ |
| Date Received | 2017-09-07 |
| Lot Number | 4274680 |
| Device Availability | N |
| Device Age | DA |
| 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 | 2017-09-07 |