MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-17 for SPRING JET I 3000-0098 manufactured by Allesee Orthodontic Appliances.
[175454321]
On (b)(6) 2020, a telephone call was made by the doctor to aoa which alleged the lingual arm of the spring jet i appliance pulled away from the solder and the patient swallowed the component. On (b)(6) 2019, the patient visited the emergency room and an x-ray was conducted. The x-ray indicated the component had passed to the intestines and the patient was directed to monitor their stool to determine if the component passes naturally. A second x-ray was conducted on (b)(6) 2019 which showed no evidence of the component. The component had passed naturally and the patient is doing fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2184045-2020-00001 |
| MDR Report Key | 9603248 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-17 |
| Date of Report | 2020-01-17 |
| Date of Event | 2019-11-20 |
| Date Mfgr Received | 2020-01-09 |
| Date Added to Maude | 2020-01-17 |
| 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 | 2628865221 |
| 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 | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPRING JET I |
| Generic Name | SPRING JET APPLIANCE |
| Product Code | DYJ |
| Date Received | 2020-01-17 |
| Model Number | 3000-0098 |
| Lot Number | 4673048 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-01-17 |