MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-05-12 for BRACE GARD 79BG4 manufactured by Dentsply Raintree Essix Glenroe.
[1487861]
It was reported that a patient was rushed to the emergency room after use of brace gard due to the patient's face being swollen and the eyes swelling shut; treatment was administered at the er. The patient presented to the office three days later and was reported as being okay.
Patient Sequence No: 1, Text Type: D, B5
[8566350]
While it is unknown if the wax 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 is reportable per 21 cfr part 803. The device is available for evaluation, though has not been returned as of this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1036212-2010-00062 |
| MDR Report Key | 1692004 |
| Report Source | 05 |
| Date Received | 2010-05-12 |
| Date of Report | 2010-04-12 |
| Date of Event | 2010-04-09 |
| Date Mfgr Received | 2010-04-12 |
| Date Added to Maude | 2010-05-19 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | HELEN LEWIS |
| Manufacturer Street | 221 W. PHILA. ST, STE 60 SUSQUEHANNA COMMERCE CTR W. |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178457511 |
| Manufacturer G1 | DENTSPLY RAINTREE ESSIX GLENROE |
| Manufacturer Street | 1912 44TH AVE., EAST |
| Manufacturer City | BRADENTON FL 34203 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 34203 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BRACE GARD |
| Product Code | EGD |
| Date Received | 2010-05-12 |
| Catalog Number | 79BG4 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY RAINTREE ESSIX GLENROE |
| Manufacturer Address | BRADENTON FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-05-12 |