MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-01-25 for RAPID PALATAL EXPANDER manufactured by Allesee Orthodontic Appliances, Sturtevant, Wi.
[98278321]
Doctor alleged the facemask hook of a rapid palatal expander broke while the patient was eating and the patient swallowed the component. Patient went to the emergency room on (b)(6) 2017, and an endoscopy under anesthesia was performed to remove the component from the patient's stomach. The patient visited the orthodontist on (b)(6) 2017, for removal of the appliance and is doing fine.
Patient Sequence No: 1, Text Type: N, H10
[98278322]
Doctor alleged the facemask hook of a rapid palatal expander broke while the patient was eating and the patient swallowed the component.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2184045-2018-00001 |
| MDR Report Key | 7220006 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-01-25 |
| Date of Report | 2018-01-02 |
| Date of Event | 2017-12-24 |
| Date Mfgr Received | 2018-01-02 |
| Device Manufacturer Date | 2017-12-06 |
| Date Added to Maude | 2018-01-25 |
| 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 |
| Manufacturer Phone | 2623213670 |
| 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 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | 2184045-2018-00001 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RAPID PALATAL EXPANDER |
| Generic Name | RETAINER, EXPANSION SCREW, ORTHODONTIC |
| Product Code | DYJ |
| Date Received | 2018-01-25 |
| Lot Number | 4360225 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALLESEE ORTHODONTIC APPLIANCES, STURTEVANT, WI |
| Manufacturer Address | 13931 SPRING STREET STURTEVANT WI 53177 US 53177 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-01-25 |