MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-01-05 for LARGE BLUE SEPARATOR ESL1000 manufactured by Dentsply Sirona Orthodontics Inc..
[96476685]
While it is unknown if the device used in this case caused or contributed to the patient's symptoms, it is possible as allergic reactions to dental materials are known and reported, with medical consequences being dependent upon the severity of the individual allergic response and subsequent exposure to the same material. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not been returned as of this report. Evaluation results will be submitted as they become available.
Patient Sequence No: 1, Text Type: N, H10
[96476686]
It was reported that a patient had separators fitted and had gone home when she developed an allergic reaction. Her face and throat started to swell. She was admitted to (b)(6) hospital where they put her on steroids and removed the separators. She is ok now and out of the hospital.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1036212-2017-00011 |
| MDR Report Key | 7167490 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-01-05 |
| Date of Report | 2018-02-16 |
| Date Mfgr Received | 2018-01-17 |
| Date Added to Maude | 2018-01-05 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. HELEN LEWIS |
| Manufacturer Street | 221 W. PHILADELPHIA ST. SUITE 60W |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178494229 |
| Manufacturer G1 | DENTSPLY SIRONA ORTHODONTICS INC. |
| Manufacturer Street | 7290 26TH COURT EAST |
| Manufacturer City | SARASOTA FL 34243 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 34243 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LARGE BLUE SEPARATOR |
| Generic Name | BAND, ELASTIC, ORTHODONTIC |
| Product Code | ECI |
| Date Received | 2018-01-05 |
| Model Number | NA |
| Catalog Number | ESL1000 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY SIRONA ORTHODONTICS INC. |
| Manufacturer Address | 7290 26TH COURT EAST SARASOTA FL 34243 US 34243 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2018-01-05 |