MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-17 for ORTHODONTIC SPRING RETAINER manufactured by Unk.
[114505230]
Patient aspirated a removable orthodontic tooth retainer, commonly known as a "spring" retainer. The appliance seats on the anterior teeth from canine to canine. It is composed of a wire framework with acrylic on the lingual and labial aspects. The patient was riding in the car, he attempted to seat the retainer and aspirated it. This was noticed immediately by parent, who transported the patient to the local hospital. It was determined that the obstruction was potentially life-threatening and that the patient would need intervention at the local children's hospital. Helicopter transport was not available, so ambulance transport was used. Thankfully, transport was uneventful. I do not have access to the medical reports, but have been informed that the retainer was retrieved from one of the bronchi under general anesthesia. The patient was sent home, is doing well at this time. He reports minor upper airway abrasion.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5078470 |
| MDR Report Key | 7697801 |
| Date Received | 2018-07-17 |
| Date of Report | 2018-07-13 |
| Date of Event | 2018-07-08 |
| Date Added to Maude | 2018-07-18 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ORTHODONTIC SPRING RETAINER |
| Generic Name | PROSTHESIS ORTHODONTIC |
| Product Code | NSR |
| Date Received | 2018-07-17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2018-07-17 |